Clinical trial NCT01324453: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
Official title: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
STEMI
Post Conditioning
Primary Percutaneous Coronary Intervention
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-03-29
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
timeFrame: Day 3-5 post-PCI
measure: Myocardial Salvage Index (MSI) on Baseline cMRI
timeFrame: Day 3-5 post-PCI
measure: Micro Vascular Obstruction (MVO) on Baseline cMRI
timeFrame: Day 3-5 post-PCI
Secondary outcomes:
measure: Global Left Ventricular Ejection Fraction
timeFrame: baseline
measure: Infarct Size by Peak Troponin
timeFrame: over first 72 hour post PCI
measure: Infarct Size by Peak Creatine Kinase (CK)
timeFrame: over first 72 hours post PCI
measure: Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
timeFrame: baseline
measure: Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
timeFrame: baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
name: Jay H Traverse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Traverse JH, Swingen CM, Henry TD, Fox J, Wang YL, Chavez IJ, Lips DL, Lesser JR, Pedersen WR, Burke NM, Pai A, Lindberg JL, Garberich RF. NHLBI-Sponsored Randomized Trial of Postconditioning During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. Circ Res. 2019 Mar;124(5):769-778. doi: 10.1161/CIRCRESAHA.118.314060.