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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT01324453
First received: March 25, 2011
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Acute Myocardial Infarction
Procedure: Post Conditioning + Primary PCI
Procedure: Standard Primary PCI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI

Resource links provided by NLM:


Further study details as provided by Minneapolis Heart Institute Foundation:

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

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

Estimated Enrollment: 140
Study Start Date: March 2011
Estimated Study Completion Date: March 2019
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT01324453     History of Changes
Other Study ID Numbers: opt004
1R01HL103927-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: March 25, 2011
Last Updated: January 24, 2017

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

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

ClinicalTrials.gov processed this record on March 23, 2017