Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction

ST-segment Myocardial Infarction Clinical Trial

— POSTCON  

Official title:

Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507156
• Other study ID #: KF 01 326257
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2007
• Last updated: October 5, 2016
• Start date: July 2007

Study information

• Verified date: October 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Description:

Please see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients more than 18 years

• STEMI < 12 hours

• TIMI 0-1 in infarct related artery

Exclusion Criteria:

• Multivessel disease (stenoses in non-infarct related arteries >70%)

• Cardiogenic shock

• Left main occlusions

• Lesions that cannot be treated with stents

• Previous CABG

• Pregnancy

• Severe renal insufficiency

• Previous extensive Q-wave infarction

• LBBB

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Myocardial Infarction

Intervention

Procedure:
• Standard primary PCI
Acute re-opening of the occluded coronary artery
• Mechanical postconditioning
Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations

Locations

Country	Name	City	State
Denmark	Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final infarct size evaluated by MR		3 month	No
Secondary	MACE (death, re-infarction, TLR)		1, 15 month	No
Secondary	Stent thrombosis		15 month	No