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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
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):

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.

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 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 MACE (death, recurrent STEMI, repeat revascularization, arrhythmias, ICD placement and hospitalization for CHF). All patients will be required to take P2Y12 inhibitors and aspirin for the duration of the trial. All patients will be treated with ACEI, beta blockers and statins.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
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
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Infarct size on baseline cMRl [ Time Frame: Day 3-5 post-PCI ]
  2. Myocardial Salvage Index (MSI) on baseline cMRI [ Time Frame: Day 3-5 post-PCI ]
  3. Micro vascular Obstruction (MVO) on baseline cMRI [ Time Frame: Day 3-5 post-PCI ]

Secondary Outcome Measures :
  1. Global Left Ventricular Ejection Fraction [ Time Frame: baseline ]
  2. Infarct size by CK and troponin peak [ Time Frame: over the first 24 hours post pci ]
  3. LV Remodeling (LVEDV) as measured by cMRl [ Time Frame: baseline ]
  4. LV Remodeling (LVESV) as measured by cMRl [ Time Frame: baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age > 18 years old, < 80 years old
  • Able to give informed consent
  • Able to undergo cMRl
  • 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
  • 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 (CrCl < 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 AS, >2+ MR)
  • Known LV systolic dysfunction (LVEF < 50% prior to STEMI)
Contacts and Locations

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

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)
Principal Investigator: Jay H Traverse, MD Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
More Information

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
Last Update Posted: January 25, 2017
Last Verified: January 2017

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

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