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

Minneapolis Heart Institute Foundation

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Myocardial Infarction

Treatments

Procedure: Post Conditioning + Primary PCI

Procedure: Standard Primary PCI

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01324453

opt004

1R01HL103927-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Single center study involving 140 patients randomized to Post Conditioning + Percutaneous coronary intervention (PCI) versus routine PCI during their ST-Elevation Myocardial Infarction (STEMI, Heart Attack) presentation. The Post Conditioning protocol consists of performing four, 30-second PTCA (Angioplasty) balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes. The first balloon inflation occurs immediately after an angioplasty guidewire is placed through the obstruction in the artery. Following this protocol the vessel is stented as part of the usual practice for treatment of STEMI. No other treatment differences will occur between the two groups and all patients will receive the usual post-STEMI care. Patients in both groups will receive a cardiac MRI 3-5 days following their STEMI for measurement of heart attack size and heart muscle function, among other measures. Patients will undergo collection of blood for creatine kinase (CK)-MB and troponin I every 8 hours for 24 hours following PCI. All patients will be followed by phone follow-up visits to review history and major adverse cardiac event (MACE) (death, recurrent STEMI, repeat revascularization, arrhythmias, implantable cardioverter-defibrillator (ICD) placement and hospitalization for congestive heart failure (CHF)). All patients will be required to take P2Y12 inhibitors and aspirin for the duration of the trial. All patients will be treated with angiotensin-converting enzyme inhibitor (ACE-I), beta blockers and statins.

Enrollment

103 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years old, < 80 years old
Able to give informed consent
Able to undergo cMRl (cardiac magnetic resonance imaging
ST-segment elevation infarction with 100% occlusion of a major epicardial vessel (> 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 < 35 mI/mm/i .73 m2)
TIMI Flow > 0 on presentation
Ischemic Time > 6 hours or < 1.0 hours
Presence of significant valvular heart disease (>mod Aortic Stenosis, >2+ Mitral Regurgitation)
Known Left Ventricular systolic dysfunction (Left Ventricular Ejection Fraction < 50% prior to STEMI)