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Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)

This study has suspended participant recruitment.
(Suspended for potential change in protocol to include different imaging modalities)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846378
First Posted: February 18, 2009
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cardiology Research UBC
Information provided by (Responsible Party):
Tarek Helmy, University of Cincinnati
  Purpose
The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

Condition Intervention Phase
Acute Myocardial Infarction Procedure: Post conditioning Procedure: Usual Care for STEMI Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Tarek Helmy, University of Cincinnati:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3. [ Time Frame: baseline, up to 3 days ]

Estimated Enrollment: 30
Study Start Date: March 2008
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.
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.
Procedure: Usual Care for STEMI
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00846378


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Cardiology Research UBC
Investigators
Principal Investigator: Tarek Helmy, MD University of Cincinnati
  More Information

Responsible Party: Tarek Helmy, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00846378     History of Changes
Other Study ID Numbers: UCIRB07051803
First Submitted: April 16, 2008
First Posted: February 18, 2009
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by Tarek Helmy, University of Cincinnati:
ST segment elevation myocardial infarction (STEMI)
timed balloon inflations
post conditioning

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications