Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction (PCinAMI)

University of Cincinnati

Status and phase: Suspended; Phase 1

Conditions: Acute Myocardial Infarction

Treatments: Procedure: Usual Care for STEMI; Procedure: Post conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00846378

UCIRB07051803

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Post conditioning

Experimental group

Description:

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.

Treatment:

Procedure: Post conditioning

Usual Care

Active Comparator group

Description:

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.

Treatment:

Procedure: Usual Care for STEMI