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Clinical Outcomes of Angioplasty Postconditioning

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Civil Hospices of Lyon

Status

Completed

Conditions

Acute Myocardial Infarction

Treatments

Procedure: Postconditioning
Procedure: standard angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00419198
2004.364

Details and patient eligibility

About

We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Full description

Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Enrollment

91 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion criteria

  • Cardiac arrest or cardiogenic shock
  • occlusion of the circumflex coronary artery

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

91 participants in 2 patient groups

1
Experimental group
Description:
Post-conditioning during angioplasty
Treatment:
Procedure: Postconditioning
2
Active Comparator group
Description:
standard angioplasty
Treatment:
Procedure: standard angioplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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