Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Post Conditioning + Primary PCI
Standard Primary PCI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, STEMI, Post Conditioning, Primary Percutaneous Coronary Intervention
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)
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Post conditioning + PCI
Standard PCI
Arm Description
Outcomes
Primary Outcome Measures
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
Infarct size was quantified by delayed, contrast-enhanced MRI
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.
Micro Vascular Obstruction (MVO) on Baseline cMRI
High T1 imaging was utilized for the determination of the presence or absence of MVO.
Secondary Outcome Measures
Global Left Ventricular Ejection Fraction
Infarct Size by Peak Troponin
Infarct Size by Peak Creatine Kinase (CK)
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.
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.
Full Information
NCT ID
NCT01324453
First Posted
March 25, 2011
Last Updated
May 22, 2019
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01324453
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, STEMI, Post Conditioning, Primary Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post conditioning + PCI
Arm Type
Experimental
Arm Title
Standard PCI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Post Conditioning + Primary PCI
Intervention Description
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
Intervention Name(s)
Standard Primary PCI
Intervention Description
Routine Percutaneous Coronary Intervention as clinically indicated.
Primary Outcome Measure Information:
Title
Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)
Description
Infarct size was quantified by delayed, contrast-enhanced MRI
Time Frame
Day 3-5 post-PCI
Title
Myocardial Salvage Index (MSI) on Baseline cMRI
Description
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.
Time Frame
Day 3-5 post-PCI
Title
Micro Vascular Obstruction (MVO) on Baseline cMRI
Description
High T1 imaging was utilized for the determination of the presence or absence of MVO.
Time Frame
Day 3-5 post-PCI
Secondary Outcome Measure Information:
Title
Global Left Ventricular Ejection Fraction
Time Frame
baseline
Title
Infarct Size by Peak Troponin
Time Frame
over first 72 hour post PCI
Title
Infarct Size by Peak Creatine Kinase (CK)
Time Frame
over first 72 hours post PCI
Title
Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl
Description
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.
Time Frame
baseline
Title
Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay H Traverse, MD
Organizational Affiliation
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30602360
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.
Results Reference
derived
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Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
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