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
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: 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 July 28, 2014