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

Acute Myocardial Infarction Clinical Trial

Official title:

Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324453
• Other study ID #: opt004
• Secondary ID: 1R01HL103927-01A
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2011
• Est. completion date: March 2017

Study information

• Verified date: May 2019
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.
• Standard Primary PCI
Routine Percutaneous Coronary Intervention as clinically indicated.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)	Infarct size was quantified by delayed, contrast-enhanced MRI	Day 3-5 post-PCI
Primary	Myocardial Salvage Index (MSI) on Baseline cMRI	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.	Day 3-5 post-PCI
Primary	Micro Vascular Obstruction (MVO) on Baseline cMRI	High T1 imaging was utilized for the determination of the presence or absence of MVO.	Day 3-5 post-PCI
Secondary	Global Left Ventricular Ejection Fraction		baseline
Secondary	Infarct Size by Peak Troponin		over first 72 hour post PCI
Secondary	Infarct Size by Peak Creatine Kinase (CK)		over first 72 hours post PCI
Secondary	Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl	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.	baseline
Secondary	Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl	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.	baseline