View Clinical Trial (Medical Research Study)
Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in STEMI
| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55407 |
| Conditions: |
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Acute Myocardial Infarction |
| Purpose: |
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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.
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| Study Summary: |
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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 72 hours following PCI. Blood will be collected from the arterial sheath for
measurements of plasma nitrite and hydrogen sulfide levels and surrogates of reactive oxygen
species (ROS) prior to reperfusion and at two timepoints following reperfusion. Patients in
both groups will receive a follow-up MRI at 3 and 12 months to assess the long term effects
of Post Conditioning on Heart Muscle function Heart chamber volumes (remodeling). All
patients will be seen in cardiology clinic at 3 and 12 months to undergo physical exam and
recording of adverse events (death, recurrent STEMI, repeat revascularization, arrhythmias
and ICD placement, hospitalization for Congestive Heart Failure). All patients will be
required to take clopidogrel (Plavix) and aspirin for the duration of the trial. All
patients will be treated with ACEI, beta blockers and statins.
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| Criteria: |
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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)
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| NCT ID: |
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NCT01324453 |
| Primary Contact: |
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Principal Investigator
Jay H Traverse, MD
Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital
Beth C Jorgenson, BSN, RN, CCRC
Phone: 612.863.6289
Email: beth.jorgenson@allina.com
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| Backup Contact: |
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Email: rachel.olson@allina.com
Rachel E Olson, MS, RN, CCRC
Phone: 612-863-3818
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| Location Contact: |
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Minneapolis, Minnesota 55407
United States
Beth C Jorgenson, BSN, RN, CCRC
Phone: 612-863-6289
Email: beth.jorgenson@allina.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
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