Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Cincinnati
Collaborator:
Interventional Cardiology Research
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00846378
First received: April 16, 2008
Last updated: November 18, 2010
Last verified: November 2010
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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 4DM 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, 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 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 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
Interventional Cardiology Research
Investigators
| Principal Investigator: | Tarek Helmy, MD | University of Cincinnati |
More Information
No publications provided
| Responsible Party: | Tarek Helmy, MD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00846378 History of Changes |
| Other Study ID Numbers: | UCIRB07051803 |
| Study First Received: | April 16, 2008 |
| Last Updated: | November 18, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Cincinnati:
|
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 |
ClinicalTrials.gov processed this record on September 26, 2012
