A Phase 3 interventional study of Exenatide and Remote Ischemic Conditioning (RIC) in ST Elevation Acute Myocardial Infarction, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 3, Interventional, and Treatment
Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment elevation myocardial infarction), but the reduction is limited. This study investigates whether a combination therapy including both therapies is more effective.
COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade > 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 378 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Remote Ischemic Conditioning + placebo
Other: Remote Ischemic Conditioning (RIC) · Drug: Placebo
Remote Ischemic Conditioning + exenatide
Drug: Exenatide · Other: Remote Ischemic Conditioning (RIC)
Sham Remote Ischemic Conditioning + placebo
Other: Remote Ischemic Conditioning (RIC) · Drug: Placebo
Sham Remote Ischemic Conditioning + exenatide
Drug: Exenatide · Other: Remote Ischemic Conditioning (RIC)
Intravenous administration of Exenatide
Remote ischemic conditioning with a cuff in the arm
Intrevenous administration of Placebo
Myocardial Infarct Size
MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.
Time frame: 3-7 days after pPCI
Myocardial salvage index
Myocardial salvage index defined as the difference between infarct size and area at risk, defined by the T2 CMRI and expressed as a percent of total LV (Left Ventricular) mass, divided by the area at risk.
Time frame: 3-7 days after pPCI
Transmurality index
Transmurality index, defined as the ratio of the mass of myocardium showing late gadolinium enhancement to the mass of the myocardial segment containing it.
Time frame: 3-7 days after pPCI
Ventricular volumes
LV (Left Ventricular) end-diastolic volume and LVEF (Left Ventricular Ejection Fraction), as determined by CMRI.
Time frame: 3-7 days after pPCI
Microvascular obstruction
Volume of myocardium with microvascular obstruction determined by late gadolinium enhancement expressed as percent of infarct size.
Time frame: 3-7 days after pPCI
Markers of successful reperfusion
Markers of successful myocardial reperfusion: ST segment resolution 90 minutes post-pPCI , TIMI flow and frame-count post-pPCI , and TIMI blush grade .
Time frame: First 90 min after reperfusion
Major adverse cardiac events (MACE)
MACE rate during hospitalization, defined as death, non-fatal myocardial rupture, or appearance or worsening of heart failure during the hospitalization period and after 1 year of follow-up
Time frame: Hospital discharge and expected average of 1 week, one year follow-up
Substudy: Biomarker analysis in Hospital Universitari Vall d'Hebron Biobank (HUVH Biobank)
To find biomarkers of increased myocardial susceptibility to reperfusion injury in blood samples obtained before PCI
Time frame: pre- pPCI
PRESPECIFIED SUBGROUP ANALYSIS ACCORDING TO TOTAL ISCHEMIC TIME
The effects of treatments will be analysed in the subgroup of patients with a total ischemic time of less than 3 hours and of 3 hours of longer.
Time frame: 3-7 days after pPCI
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute