NCT00419198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 28, 2019

Status Verified

March 1, 2010

Enrollment Period

2.5 years

First QC Date

January 5, 2007

Last Update Submit

May 23, 2019

Conditions

Keywords

IschemiaReperfusionMyocardial infarctionPostconditioning

Outcome Measures

Primary Outcomes (1)

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

    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.

    at 6 month

Study Arms (2)

1

EXPERIMENTAL

Post-conditioning during angioplasty

Procedure: Postconditioning

2

ACTIVE COMPARATOR

standard angioplasty

Procedure: standard angioplasty

Interventions

Postconditioning during angioplasty

1

standard angioplasty without postconditioning

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michel Ovize

Lyon, 69677, France

Location

Related Publications (1)

  • Thibault H, Piot C, Staat P, Bontemps L, Sportouch C, Rioufol G, Cung TT, Bonnefoy E, Angoulvant D, Aupetit JF, Finet G, Andre-Fouet X, Macia JC, Raczka F, Rossi R, Itti R, Kirkorian G, Derumeaux G, Ovize M. Long-term benefit of postconditioning. Circulation. 2008 Feb 26;117(8):1037-44. doi: 10.1161/CIRCULATIONAHA.107.729780. Epub 2008 Feb 11.

MeSH Terms

Conditions

IschemiaMyocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • michel Ovize, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

September 1, 2005

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

May 28, 2019

Record last verified: 2010-03

Locations