Back to resultsClinical Outcomes of Angioplasty Postconditioning
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Postconditioning
standard angioplasty
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Myocardial Infarction focused on measuring Ischemia, Reperfusion, Myocardial infarction, Postconditioning
Eligibility Criteria
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
Sites / Locations
- Michel Ovize
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Post-conditioning during angioplasty
standard angioplasty
Outcomes
Primary Outcome Measures
Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
Secondary Outcome Measures
Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419198
Brief Title
Clinical Outcomes of Angioplasty Postconditioning
Official Title
Postconditioning and Functional Recovery After Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Ischemia, Reperfusion, Myocardial infarction, Postconditioning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Post-conditioning during angioplasty
Arm Title
2
Arm Type
Active Comparator
Arm Description
standard angioplasty
Intervention Type
Procedure
Intervention Name(s)
Postconditioning
Intervention Description
Postconditioning during angioplasty
Intervention Type
Procedure
Intervention Name(s)
standard angioplasty
Intervention Description
standard angioplasty without postconditioning
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.
Time Frame
at 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michel Ovize, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michel Ovize
City
Lyon
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
18268150
Citation
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.
Results Reference
result
Learn more about this trial
Clinical Outcomes of Angioplasty Postconditioning
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