Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— PCinAMI  

Official title:

The Mechanism of Ischemic Post-conditioning in Humans: Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00846378
• Other study ID #: UCIRB07051803
• Status: Suspended
• Phase: Phase 1
• First received: April 16, 2008
• Last updated: January 31, 2014
• Start date: March 2008

Study information

• Verified date: January 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Reperfusion Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Cardiology Research UBC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software		6 weeks	No
Primary	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.		6 weeks	No
Primary	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.		baseline, every 8 hours x 3	No
Primary	ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.		baseline, up to 3 days	No