Phase 2 N=103 Randomized Treatment

Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)

Acute Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT01324453 ↗

Enrolled (actual)

103

Serious AEs

3.9%

Results posted

Apr 2018

Primary outcome: Primary: Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI) — 20.1; 21.0 ml — p=0.90

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Post Conditioning + Primary PCI (Procedure); Standard Primary PCI (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Minneapolis Heart Institute Foundation
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)	20.1; 21.0	0.90
PRIMARY Myocardial Salvage Index (MSI) on Baseline cMRI	32.6; 32.7	0.81
PRIMARY Micro Vascular Obstruction (MVO) on Baseline cMRI	31; 25	0.45
SECONDARY Global Left Ventricular Ejection Fraction	55.1; 54.0	0.58
SECONDARY Infarct Size by Peak Troponin	19.63; 14.44	0.86
SECONDARY Infarct Size by Peak Creatine Kinase (CK)	1701; 1619	1.00
SECONDARY Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl	149; 147	0.58
SECONDARY Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl	70; 65	0.77

Summary

This study will evaluate change in heart muscle function from baseline to three months and twelve months in participants who present with a heart attack and a completely occluded coronary artery. These subjects will be randomized to receive standard Percutaneous transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting plus post conditioning. Post conditioning commences immediately upon reperfusion using four cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size of the heart attack when utilized with successful primary Angioplasty/stent.

Eligibility Criteria

Inclusion Criteria

Age > 18 years old, 2.5 mm)
No angiographic evidence of collateral flow distal to occluded artery
Ischemic duration between 1.0 and 6 hours
Thrombolysis in myocardial infarction (TIMI) 3 Flow following PCI

Exclusion Criteria

Visible collateral blood flow to the distal vasculature of the occluded vessel
Previous Coronary Artery Bypass Graft surgery
Previous q-wave myocardial infarction in the same territory
Inability to give informed consent
Inability to undergo cMRl
Life expectancy less than one year
History of Non-compliance or alcohol or drug addiction
Patients with cardiogenic shock, cardiac arrest, hypothermia on presentation
Chronic dialysis or significant renal insufficiency (Creatinine Clearance 0 on presentation
Ischemic Time > 6 hours or mod Aortic Stenosis, >2+ Mitral Regurgitation)
Known Left Ventricular systolic dysfunction (Left Ventricular Ejection Fraction < 50% prior to STEMI)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01324453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.