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:
Collaborator:
Cardiology Research UBC
Information provided by (Responsible Party):
Tarek Helmy, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00846378
First received: April 16, 2008
Last updated: January 31, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3. [ Time Frame: baseline, up to 3 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tarek Helmy, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00846378     History of Changes
Other Study ID Numbers: UCIRB07051803
Study First Received: April 16, 2008
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014