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

Completed · Phase 1/Phase 2

Conditions studied: Acute Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT01324453

Run by

Minneapolis Heart Institute Foundation

People needed

103

Starts

2011-03-01

Expected to finish

2017-03-01

Last updated by the study team

2019-06-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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