Myocardial Infarction Clinical Trial
Official title:
Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A Multicenter, Randomized Trial Comparing Early and Late Intracoronary or Combined (Intramyocardial and Intracoronary) Administration of Stem Cells
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of bone marrow-derived stem cells to patients after acute myocardial infarction with reopened infarct-related artery.
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size
and beneficially affect the postinfarction remodeling.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is
a multicenter, prospective, randomized, single-blind clinical trial designed to compare the
early and late intracoronary or combined (percutaneous intramyocardial and intracoronary)
administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened
infarct-related artery.
The primary endpoints are the changes in resting myocardial perfusion defect size and left
ventricular ejection fraction (gated SPECT scintigraphy) 3 months after BM-SCs therapy.
The secondary endpoints relate to evaluation of 1) the safety and feasibility of the
application modes, 2) the changes in left ventricular wall motion score index (transthoracic
echocardiography), 3) myocardial voltage and segmental wall motion (NOGA mapping), 4) left
ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and 5) the
clinical symptoms (CCS and NYHA) at follow-up.
Patients are randomly assigned into one of four groups, Group A: early treatment (21-42 days
after AMI) with intracoronary injection; Group B: early treatment (21-42 days after AMI)
with combined (intramyocardial and intracoronary) application; Group C: late treatment (3
months after AMI) with intracoronary delivery; and Group D: late treatment (3 months after
AMI) with combined (intramyocardial and intracoronary) administration of BM-SCs. Besides the
BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
The MYSTAR trial is the first randomized trial to investigate the effects of the combined
(intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy
in the early and late periods after AMI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), 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 |