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

NCT ID: NCT01324453

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post conditioning + PCI

Group Type: EXPERIMENTAL

Post Conditioning + Primary PCI

Intervention Type: PROCEDURE

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 PCI

Group Type: ACTIVE_COMPARATOR

Standard Primary PCI

Intervention Type: PROCEDURE

Routine Percutaneous Coronary Intervention as clinically indicated.

Interventions

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.

Intervention Type: PROCEDURE

Standard Primary PCI

Routine Percutaneous Coronary Intervention as clinically indicated.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay H Traverse, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30602360 (View on PubMed)

Other Identifiers

1R01HL103927-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

opt004

Identifier Type: -

Identifier Source: org_study_id