Myocardial Infarction Clinical Trial
Official title:
A Phase 1b/2a Dose Escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
Primary Objective The primary objective of this study is to evaluate the safety and
feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping
Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and
150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
SecondaryObjective
The secondary objectives are to explore functional efficacy for subsequent study design, as
well as late-term dose related tolerance, by:
- Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to
cardiac function on Days 90, 180, and 1 year
- Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36),
Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New
York Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years
- Evaluating follow-up safety through Day 360
- Providing preliminary data to support dose selection for future studies
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
| Completed |
NCT04507529 -
Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients
|
N/A | |
| Recruiting |
NCT06066970 -
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
|
||
| Recruiting |
NCT03620266 -
Effects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI
|
N/A | |
| Completed |
NCT04097912 -
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
|
||
| Completed |
NCT04153006 -
Comparison of Fingerstick Versus Venous Sample for Troponin I.
|
||
| Completed |
NCT03668587 -
Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement
|
||
| Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
| Completed |
NCT03076801 -
Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?
|
N/A | |
| Recruiting |
NCT05371470 -
Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
|
N/A | |
| Recruiting |
NCT04562272 -
Attenuation of Post-infarct LV Remodeling by Mechanical Unloading Using Impella-CP
|
N/A | |
| Completed |
NCT04584645 -
A Digital Flu Intervention for People With Cardiovascular Conditions
|
N/A | |
| Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
| Not yet recruiting |
NCT06007950 -
Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health
|
N/A | |
| Withdrawn |
NCT05327855 -
Efficacy and Safety of OPL-0301 Compared to Placebo in Adults With Post-Myocardial Infarction (MI)
|
Phase 2 | |
| Recruiting |
NCT02876952 -
High Intensity Aerobic Interval Training With Mediterranean Diet Recommendations in Post-Myocardial Infarct Patients
|
N/A | |
| Completed |
NCT02711631 -
Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
|
N/A | |
| Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
| Completed |
NCT02552407 -
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
|
N/A | |
| Completed |
NCT02305602 -
A Study of VentriGel in Post-MI Patients
|
Phase 1 |