Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Cincinnati.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
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 May 19, 2013