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

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ClinicalTrials.gov Identifier: NCT01324453
Recruitment Status : Active, not recruiting
First Posted : March 29, 2011
Results First Posted : April 17, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Post Conditioning + Primary PCI Procedure: Standard Primary PCI Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
Study Start Date : March 2011
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Post conditioning + PCI 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.

Active Comparator: Standard PCI Procedure: Standard Primary PCI
Routine Percutaneous Coronary Intervention as clinically indicated.




Primary Outcome Measures :
  1. Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI) [ Time Frame: Day 3-5 post-PCI ]
    Infarct size was quantified by delayed, contrast-enhanced MRI

  2. Myocardial Salvage Index (MSI) on Baseline cMRI [ Time Frame: Day 3-5 post-PCI ]
    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.

  3. Micro Vascular Obstruction (MVO) on Baseline cMRI [ Time Frame: Day 3-5 post-PCI ]
    High T1 imaging was utilized for the determination of the presence or absence of MVO.


Secondary Outcome Measures :
  1. Global Left Ventricular Ejection Fraction [ Time Frame: baseline ]
  2. Infarct Size by Peak Troponin [ Time Frame: over first 72 hour post PCI ]
  3. Infarct Size by Peak Creatine Kinase (CK) [ Time Frame: over first 72 hours post PCI ]
  4. Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl [ Time Frame: baseline ]
    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.

  5. Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl [ Time Frame: baseline ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324453


Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jay H Traverse, MD Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT01324453     History of Changes
Other Study ID Numbers: opt004
1R01HL103927-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2011    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: May 22, 2018
Last Verified: April 2018

Keywords provided by Minneapolis Heart Institute Foundation:
Acute Myocardial Infarction
STEMI
Post Conditioning
Primary Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases