Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01324453|
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Results First Posted : April 17, 2018
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Procedure: Post Conditioning + Primary PCI Procedure: Standard Primary PCI||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||March 2019|
|Experimental: Post conditioning + PCI||
Procedure: Post Conditioning + Primary PCI
Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
|Active Comparator: Standard PCI||
Procedure: Standard Primary PCI
Routine Percutaneous Coronary Intervention as clinically indicated.
- Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI) [ Time Frame: Day 3-5 post-PCI ]Infarct size was quantified by delayed, contrast-enhanced MRI
- Myocardial Salvage Index (MSI) on Baseline cMRI [ Time Frame: Day 3-5 post-PCI ]The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR — Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.
- Micro Vascular Obstruction (MVO) on Baseline cMRI [ Time Frame: Day 3-5 post-PCI ]High T1 imaging was utilized for the determination of the presence or absence of MVO.
- Global Left Ventricular Ejection Fraction [ Time Frame: baseline ]
- Infarct Size by Peak Troponin [ Time Frame: over first 72 hour post PCI ]
- Infarct Size by Peak Creatine Kinase (CK) [ Time Frame: over first 72 hours post PCI ]
- Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl [ Time Frame: baseline ]LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole.
- Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl [ Time Frame: baseline ]LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324453
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Jay H Traverse, MD||Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital|