Clinical Trials

Saint Luke's Research strives to continuously improve the quality and value of health care as a national leader in clinical, translational, and outcomes research. Review our currently active studies listed by specialty, primary indication, or trial short name. For more information about a trial, reach out to the contact email listed.

Cardiology

Amyloidosis

CARS
Cardiac Amyloidosis Registry Study ("CARS")
cvheartfailureresearchnurse@saint-lukes.org
NCT05174338
Brett Sperry, MD

MAGNITUDE
MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy
cvheartfailureresearchnurse@saint-lukes.org
NCT06128629
Brett Sperry, MD

DepleTTR-CM
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
cvheartfailureresearchnurse@saint-lukes.org
NCT06183931
Brett Sperry, MD

PYP Pfizer
Quantitative assessment of technetium pyrophosphate washout in patients with light chain and transthyretin cardiac amyloidosis
cvheartfailureresearchnurse@saint-lukes.org
Brett Sperry, MD

ACT-EARLY
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
cvheartfailureresearchnurse@saint-lukes.org
NCT06563895
Brett Sperry, MD

Aortic Stenosis

ENVISION
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement
cvresearch@saint-lukes.org
NCT05932615
Adnan Chhatriwalla, MD

PROGRESS CAP
SAPIEN 3/SAPIEN 3 Ultra/SAPIEN 3 Ultra RESILIA Moderate AS PROGRESS Trial Access
cvresearch@saint-lukes.org
NCT04889872
Adnan Chhatriwalla, MD

Aortic Valve

PARADIGM
PARAvalvular leak closure with the Amplatzer Valvular Plug occluDer for Interventional transcatheter closure for PVL with surgical bioloGical and Mechanical heart valve
cvresearch@saint-lukes.org
NCT04489823
Chetan Huded, MD

PROTEMBO
Cerebral Protection in Transcatheter Aortic Valve Replacement – The PROTEMBO Trial
cvresearch@saint-lukes.org
NCT05873816
Adnan Chhatriwalla, MD

Atrial Fibrillation: PACeS
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG
cvsurgeryresearch@saint-lukes.org
NCT04045665
Keith Allen, MD

Cardiopulmonary bypass: ARTEMIS
ARTEMIS: RAvulizumab to PRotect PaTients with Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
cvsurgeryresearch@saint-lukes.org
NCT05746559
Sean McCarney, MD

Cardiothoracic surgery

LeAAPS
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
cvsurgeryresearch@saint-lukes.org
NCT05478304
Michael Gibson, MD

ORCAH
A Prospective, Multi-Center, Single-Blind, Randomized, Active-Controlled- Study of BD ORC Original Absorbable Hemostat Compared with Surgicel® Original Absorbable Hemostat
cvsurgeryresearch@saint-lukes.org
NCT05741463
Keith Allen, MD

CTSN – EMBOLIC
EMBOLIC PROTECTION IN PATIENTS UNDERGOING HIGHRISK VALVE SURGERY
NCT: NCT06027788
cvsurgeryresearch@saint-lukes.org
Keith Allen, MD

REDUCE
The Cryoanalgesia Registry for Pain Management in Post-cardiothoracic Surgery Via Cryoablation of the intercostal nerves Registry (REDUCE Registry)
cvsurgeryresearch@saint-lukes.org
NCT05110989
Michael Gibson, MD

Coronary Artery Disease: PCORI RECHARGE
REvascularization CHoices Among under-Represented Groups Evaluation (The RECHARGE Trial)
interventionalresearch2@saint-lukes.org
NCT06399705
Adam Salisbury, MD

Diabetes: TRANSFORM CVRiD
TRANSFORM CV Risk in Diabetes
cvcardiometaresearch@saint-lukes.org
NCT05948969
Andrew Sauer, MD

Echo: ACCESS
MVT-100: Advancing the clinical use of perflutren ultrasound contrast agents for suboptimal echocardiograms
generalcardioresearch@saint-lukes.org
NCT03882359
Michael Main, MD

Electrophysiology

Product Surveillance Registry
Product Surveillance Registry (PSR) Platform Base Protocol
EPResearch@saint-lukes.org
NCT01524276
Brian Ramza, MD

TRACER ICD
TRAjectories and Clinical ExpeRiences of ICD Therapy
EPResearch@saint-lukes.org
NCT05116176
Daniel Steinhaus, MD

PIPER-ICD
Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs
EPResearch@saint-lukes.org
Daniel Steinhaus, MD

INTEGRA-D
INTEGRA-D Clinical Trial: Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction
EPResearch@saint-lukes.org
NCT05855135
Daniel Steinhaus, MD

Sensation
SENSATION: TREATMENT OF SYMPTOMATIC DRUG REFRACTORY PAROXYSMAL ATRIAL FIBRILLATION WITH THE SYNAPTIC COMPLIANT CRYOABLATION BALLOON AND SYSTEM
EPResearch@saint-lukes.org
NCT05905835
Sanjaya Gupta, MD

SIMPLAAFY
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
EPResearch@saint-lukes.org
NCT06521463
Chetan Huded, MD

ADVENT LTO
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression (ADVENT LTO Study)
EPResearch@saint-lukes.org
NCT06526546
Sanjaya Gupta, MD

Heart Failure

PROACTIVE-HF-2
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II -III Heart Failure Patients (PROACTIVE- HF-2 Trial)
cvheartfailureresearchnurse@saint-lukes.org
NCT05934487
Michael Nassif, MD

REDEFINE-HF
RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart
cvcardiometaresearch@saint-lukes.org
NCT06008197
Andrew Sauer, MD

HF2
HF2 Registry – Hemodynamic Frontiers in Heart Failure Registry
cvheartfailureresearchnurse@saint-lukes.org
Timothy Fendler, MD

CONFIRMATION
COmbiNed eFfIcacy and safety of an eaRly, intensive MAnagement sTrategy with fInerenOne and SGLT2 iNhibitor in patients hospitalized with Heart Failure (CONFIRMATION-HF)
cvcardiometaresearch@saint-lukes.org
NCT06024746
Andrew Sauer, MD

FINALITY
A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists
cvcardiometaresearch@saint-lukes.org
NCT06033950
Andrew Sauer, MD

COMET-HF
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of an oral HF therapy in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction
cvheartfailureresearchnurse@saint-lukes.org
NCT06736574
Andrew Kao, MD

Hypertension: US GPS
The Global Paradise® System US Post Approval Study
interventionalresearch2@saint-lukes.org
NCT06297291
Steven Laster, MD

Hypertrophic Cardiomyopathy: FOREST_HCM (Previously REDWOOD-OLE)
An Open-Label Study of CK3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM)
cvheartfailureresearchnurse@saint-lukes.org
NCT04848506
Michael Nassif, MD

Mitral Valve

SUMMIT
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
cvresearch@saint-lukes.org
NCT03433274
Keith Allen, MD

PRIMARY
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds
cvsurgeryresearch@saint-lukes.org
NCT05051033
Keith Allen, MD

Myocardial Ischemia: MICRO Validation
Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With the Absence of Obstructive Coronary Artery Disease (MICRO VALIDATION)
interventionalresearch2@saint-lukes.org
NCT06212466
Dany Jacob, MD

Percutaneous Coronary Intervention (PCI)

Cosira II
Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II (COSIRA-II)
interventionalresearch2@saint-lukes.org
NCT05102019
Anthony Hart, MD

Short-Cut
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease – A Randomized Controlled Trial (Short-Cut)
interventionalresearch2@saint-lukes.org
NCT06089135
Dmitri Baklanov, MD

Postural orthostatic tachycardia syndrome (POTS)

POTS
A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients with Postural Orthostatic Tachycardia Syndrome
EPResearch@saint-lukes.org
NCT06593600
John Lee, MD

Valvular diseases: Explanted Heart Valve Registry
cvsurgeryresearch@saint-lukes.org
Keith Allen, MD

Women's cardiovascular health

REBIRTH
Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy (REBIRTH)
cvwomenshealthresearch@saint-lukes.org
NCT05180773
Anna Grodzinsky, MD

HOPE
Heart Outcomes in Pregnancy Expectations (HOPE) for Mom and Baby
NCT06517628
cvwomenshealthresearch@saint-lukes.org
Anna Grodzinsky, MD

Maternal Mortality Study
Perceptions of Maternal Mortality in Women across Missouri
cvwomenshealthresearch@saint-lukes.org
Laura Schmidt, MD

Pregnancy Complications Registry
Pregnancy Complications Leading to Cardiovascular Disease Outcomes Registry
cvwomenshealthresearch@saint-lukes.org
Valerie Rader, MD

Oncology

Advanced Solid Tumors

Scorpion
First-in-Human Study of STX-478, a H1047X Mutation-specific PI3Kα Inhibitor as Monotherapy and in Combination with Other Antineoplastic Agents in Advanced Solid Tumor Patients
slhbreastcancerresearch@saint-lukes.org
NCT05768139
Timothy Pluard, MD

Seagen-004
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
slhbreastcancerresearch@saint-lukes.org
NCT06157892
Timothy Pluard, MD

Recursion
A Phase 2, Open-Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation
slhGIoncologyresearch@saint-lukes.org
NCT06005974
Marc Roth, MD

Exelixis
An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients with Advanced Solid Tumors
slhbreastcancerresearch@saint-lukes.org
NCT05932862
Timothy Pluard, MD

Breast Cancer

CAMBRIA-2
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
slhbreastcancerresearch@saint-lukes.org
NCT05952557
Whitney Hensing, MD

ELAINE 3
Phase 3 open label study comparing efficacy and safety of the combination of lasofoxifene and abemaciclib to the combination of fulvestrant and abemaciclib for the treatment of adults with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation
slhbreastcancerresearch@saint-lukes.org
NCT05696626
Timothy Pluard, MD

COMPASS HER2
CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinb
slhbreastcancerresearch@saint-lukes.org
NCT04457596
Whitney Hensing, MD

DYNASTY-Breast02
A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy
slhbreastcancerresearch@saint-lukes.org
NCT06018337
Timothy Pluard, MD

OptimICE-pCR
OptimICE-pCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy
slhbreastcancerresearch@saint-lukes.org
NCT05812807
Whitney Hensing, MD

EmpowHER 303
A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment
slhbreastcancerresearch@saint-lukes.org
NCT06435429
Timothy Pluard, MD

Colorectal Cancer: Cardiff CRDF-004
A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
slhGIoncologyresearch@saint-lukes.org
NCT06106308
Marc Roth, MD

Gastric Varices: CLARITY GC01
A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2, D9802C00001.
slhGIoncologyresearch@saint-lukes.org
NCT06346392
Marc Roth, MD

Hepatocellular Carcinoma (Hcc): Genentech
A Phase II, Open-Label, Multicohort, Multicenter Study in Patients with Hepatocellular Carcinoma and Child-Pugh B Cirrhosis.
slhGIoncologyresearch@saint-lukes.org
NCT06096779
Marc Roth, MD

Lung Cancer: Amgen 193
20230167: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 alone or in Combination with other Therapies in Subjects with Advanced Thoracic Tumors with homozygous MTAP Deletion
slhthoraciccancerresearch@saint-lukes.org
NCT06333951
Timothy Pluard, MD

Non-Small-Cell Lung Cancer (NSCLC)

Alchemist sub-study
A081801 Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO
slhthoraciccancerresearch@saint-lukes.org
NCT04267848
Thomas Bemis, MD

M18-868
A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
slhthoraciccancerresearch@saint-lukes.org
NCT04928846
Marc Roth, MD

Pancreatic cancer: PRISM-1
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma
slhgastroenterology@saint-lukes.org
NCT06608927
Marc Roth, MD

Physical Therapy: Physical Activity in MBC
The effect of regular physical activity and virtual exercise intervention on physical functions, fatigue, mental health, and disease progression in Metastatic Breast Cancer (MBC)
slhbreastcancer@saint-lukes.org
MacKenzie Messina

Neuro-Oncology

Brain Cancer
Dogwood
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
slhneurooncresearch@saint-lukes.org
NCT05359133
Samuel Goldlust, MD

RESTORE
A Phase 2 Study of NanO2(TM) Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM (RESTORE)
slhneurooncresearch@saint-lukes.org
NCT03862430
Samuel Goldlust, MD

MOAB
A multicenter trial to identify optimal atezolizumab biomarkers in the setting of recurrent gliobastoma. The MOAB Trial
slhneurooncresearch@saint-lukes.org
NCT06069726
Samuel Goldlust, MD

Neurology

Ischemic Stroke
SATURN
Statins use in intracerebral hemorrhage patients
NeuroscienceResearch@saint-lukes.org
NCT03936361
Karin Olds, MD

SleepSMART
Sleep for Stroke Management And Recovery Trial
NeuroscienceResearch@saint-lukes.org
NCT03812653
Karin Olds, MD

StrokeNet REASSESS ICH
REpeated ASSEssment of SurvivorS in IntraCerebral Hemorrhage study
NeuroscienceResearch@saint-lukes.org
NCT05611918
Karin Olds, MD

Neurosurgery
3D Model
Evaluating the Impact of 3D Printed Spine Models on Patient Understanding and Satisfaction
NeuroscienceResearch@saint-lukes.org
Carlos Bagley, MD

Stroke (neuroprotection)
ARPEGGIO
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke
NeuroscienceResearch@saint-lukes.org
NCT05585606
Coleman Martin, MD

REVERXal
A multinational observational longitudinal study to describe the patient characteristics, health care interventions, and health outcomes of patients with major bleedings in the presence of Factor Xa inhibitor treatment
NeuroscienceResearch@saint-lukes.org
NCT06147830
Carlos Bagley, MD

Audiology

Hearing
Perimodiolar Implant
A pre-market, open-label feasibility, prospective, single-arm multicenter feasibility investigation of hearing performance using the Cl632 in adults with low-frequency residual hearing.
AudiologyResearch@saint-lukes.org
NCT04741009
Robert Cullen, MD

ACE
A pivotal, prospective, open-label, multi-center study of safety and effectiveness of cochlear implantation in an expanded population of adults with bilateral sensorineural hearing loss
AudiologyResearch@saint-lukes.org
NCT06293482
Sarah Zlomke, AuD

General Surgery

Ventral Hernia
BRAVO II
A Prospective Study Evaluating the Clinical Outcomes of Ventral Hernias treated Robotically with OviTex® Reinforced Tissue Matrix
genericresearchpatrequest@saint-lukes.org
NCT04779918
Geoffrey Slayden, MD

Nursing

Post-ICU Delirium
SPECTOR
Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: A Randomized Control Trial
mebberts@saint-lukes.org
Katie Callahan, RN

Ischemic Stroke
Stroke Recovery Mindfulness
Mindfulness based recovery from stroke: a pilot study
etompkins@saintlukeskc.org
Erin Tompkins, RN

Pain Management

Pain & Polyneuropathy

SENZA- PDN PM
A Post-Market, Multicenter, Prospective, Global Clinical Study to evaluate the real-world experience of Spinal Cord Stimulation that includes 10 kHz in the management of chronic intractable pain associated with diabetic neuropathy
genericresearchpatrequest@saint-lukes.org
NCT05301816
Jennifer Elliott, MD

Pulmonary

Idiopathic Pulmonary Fibrosis (IPF)

TETON
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
genericresearchpatrequest@saint-lukes.org
NCT04708782
Mark Yagan, MD

Lung Nodules

NIGHTINGALE
NIGHTINGALE: CliNIcal Utility of ManaGement of Patients witH CT and LDCT Identified Pulmonary Nodules UsinG the Percepta NasAL Swab ClassifiEr – with Familiarization
genericresearchpatrequest@saint-lukes.org
NCT06426628
Matthew Aboudara, MD

Pulmonary Fibrosis

TETON-PPF
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)
genericresearchpatrequest@saint-lukes.org
NCT05943535
Mark Yagan, MD

Radiology

Pulmonary Embolism (Radiology)

PEERLESS II
RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
generalcardioresearch@saint-lukes.org
NCT06055920
Jennifer Buckley, MD