Myocardial Infarction Clinical Trial
Official title:
A Phase 1 Randomized, Double-blind, Placebo-controlled, Dose Escalation, Multicenter Study to Determine the Safety of Intravenous Ex-vivo Cultured Adult Human Mesenchymal Stem Cells (Provacel) Following Acute Myocardial Infarction
The purpose of the study is to determine whether adult stem cells [Provacel™(PUMP1)] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).
Cardiovascular disease is the single largest killer of males and females in the United States
with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will
suffer an acute myocardial infarction. The standard of care treatment for acute myocardial
infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or
other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk
factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and
exercise all work to reduce further atherosclerotic events. Yet, many patients go on to
develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and
slow the progression to failure but does not restore a functioning myocardium. A therapy that
could improve the myocardial remodeling process and reduce the incidence or severity of CHF
following acute MI would provide a significant benefit in an area of unmet medical need.
Patients will receive standard of care in addition to stem cells or placebo.
;
| 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 |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
| Completed |
NCT02711631 -
Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
|
N/A | |
| Completed |
NCT02305602 -
A Study of VentriGel in Post-MI Patients
|
Phase 1 | |
| Completed |
NCT02552407 -
Thrombectomy in ST Elevation Myocardial Infarction, an Individual Patient Meta-analysis
|
N/A |