- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846378
Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)
January 31, 2014 updated by: Tarek Helmy, University of Cincinnati
The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size.
This intervention is hypothesized to be safe in humans.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- STEMI
- Onset of symptoms within 6 hours
- TIMI 0 to TIMI 1 flow in infarct related artery
Exclusion Criteria:
- collaterals to infarct related artery
- previous infarct in related territory
- thrombolytics
- cardiogenic shock
- TIMI 2 to TIMI 3 flow
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post conditioning
After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds.
The balloon should be inflated to only occlude the coronary artery.
This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
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after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds.
This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
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Active Comparator: Usual Care
Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery.
Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
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Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery.
Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software
Time Frame: 6 weeks
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6 weeks
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Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.
Time Frame: 6 weeks
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6 weeks
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Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.
Time Frame: baseline, every 8 hours x 3
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baseline, every 8 hours x 3
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ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.
Time Frame: baseline, up to 3 days
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baseline, up to 3 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
April 16, 2008
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
February 3, 2014
Last Update Submitted That Met QC Criteria
January 31, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCIRB07051803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction
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Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
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Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
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Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
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Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
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Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
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Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
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Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
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Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
-
Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on Post conditioning
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University of CalgaryFoothills Interventional Cardiology Research GroupCompleted
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Samsung Medical CenterCompletedMyocardial Infarction | Myocardial ReperfusionKorea, Republic of
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Minneapolis Heart Institute FoundationSociety for Cardiovascular Angiography and InterventionsCompleted
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Capital Medical UniversityCompletedAcute Ischemic StrokeChina
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Chonnam National University HospitalTerminatedOut-Of-Hospital Cardiac ArrestKorea, Republic of
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Beth Israel Deaconess Medical CenterUnknown
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José García de la AsunciónCompleted
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Tianjin Huanhu HospitalRecruitingAcute Ischemic Stroke | Large Vessel Occlusion | Endovascular ThrombectomyChina
-
Capital Medical UniversityRecruitingReperfusion Injury | Acute Ischemic StrokeChina
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Minneapolis Heart Institute FoundationNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Myocardial InfarctionUnited States