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OpenTrials
Completed

NCT Number: NCT00419198

Clinical Outcomes of Angioplasty Postconditioning

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.

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michel Ovize

Lyon, 69677, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postconditioning

Procedure

Postconditioning during angioplasty

standard angioplasty

Procedure

standard angioplasty without postconditioning

Primary outcomes

  1. Infarct size as measured by cardiac enzymes and MRI at day 5 to 7

    Time frame: during 72 hours after angioplasty, and at day 5 to 7

Secondary outcomes

  1. Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.

    Time frame: at 6 month

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Postconditioning and Functional Recovery After Acute Myocardial Infarction

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 8, 2007
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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