Effects of Postconditioning On Myocardial Reperfusion

Myocardial Infarction Clinical Trial

— POST  

Official title:

Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942500
• Other study ID #: 2009-02-007
• Status: Completed
• Phase: N/A
• First received: July 13, 2009
• Last updated: October 31, 2012
• Start date: July 2009
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria General Inclusion Criteria

• Subject must be at least 18 years of age.

• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

• Diagnosis of STEMI

1. presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset

2. ST-segment elevation more than 1 mm in at least 2 contiguous leads

Angiographic Inclusion Criteria

• Target lesion(s) must be located in a native coronary artery

• Target lesion(s) must be amenable for percutaneous coronary intervention

• TIMI flow grade of infarct related arteries <2

General Exclusion Criteria

• Patients with hemodynamic instability or those with cardiogenic shock

• Target lesion is located in left main stem

• Rescue PCI after thrombolysis or facilitated PCI

• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Reperfusion

Intervention

Procedure:
• Post-conditioning
Coronary angiogram is performed to allow identification of the culprit coronary artery and to check no reperfusion before PCI (TIMI grade <2). Restoration of coronary blood flow can be achieved by thrombus aspiration, balloon angioplasty, direct stenting or together.In the postconditioning group, immediately after restoration (TIMI grade =2) of coronary flow (without regard to method of achieving restoration), angioplasty balloon will be positioned at the culprit lesion or stented segment and inflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations, each separated by 1 minute of reflow. When restoration of coronary flow is achieved by thrombus aspiration or balloon angioplasty and residual stenosis is remained =30%, stent will be deployed.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The dichotomous rate of complete ST-segment resolution (STR)		at 30 minutes after final contrast injection	No
Secondary	Myocardial blush grade		within 10 minutes after PCI	No
Secondary	Thrombolysis in Myocardial Infarction (TIMI) flow grade		within 10 minutes after PCI	No
Secondary	Angiographic no-reflow		during PCI	No
Secondary	All death		at 30 days and 1 year	Yes
Secondary	Stent thrombosis		at 30 days and 1 year	Yes
Secondary	Cardiac death		at 30 days and 1 year	Yes
Secondary	Myocardial infarction		at 30 days and 1 year	Yes
Secondary	Severe heart failure	Severe heart failure was defined as heart failure with documented arterial partial pressure of oxygen less than 60 mmHg or with pulmonary edema documented radiographically or requiring intubation, 100% oxygen, or insertion of a mechanical support device.	at 30 days and 1 year	No
Secondary	Target vessel revascularization (TVR)		at 30 days and 1 year	No
Secondary	Composite of death, MI, severe heart failure, or stent thrombosis		at 30 days and 1 year	Yes