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Clinical Outcomes of Angioplasty Postconditioning

Postconditioning and Functional Recovery After Acute Myocardial Infarction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00419198
Enrollment
91
Registered
2007-01-08
Start date
2005-09-30
Completion date
2008-12-31
Last updated
2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Ischemia, Reperfusion, Myocardial infarction, Postconditioning

Brief summary

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.

Detailed 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.

Interventions

Postconditioning during angioplasty

standard angioplasty without postconditioning

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Infarct size as measured by cardiac enzymes and MRI at day 5 to 7during 72 hours after angioplasty, and at day 5 to 7

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026