Intracoronary Thrombus Assessed by OFDI After Successful Fibrinolysis And Its Impact On Myocardial Reperfusion

NCT ID: NCT02850315

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-05-31

Brief Summary

The pharmacoinvasive approach after thrombolysis is the standard treatment of myocardial infarction when deadlines are too long for primary angioplasty. Coronary angioplasty is then carried out within 3 to 24 hours following thrombolysis. The adjuvant antiplatelet therapy of thrombolysis combines aspirin with clopidogrel (75 or 300 mg depending on age). These clopidogrel doses are associated with a very low anti-platelet aggregation response within 24 hours following administration. However, the antiplatelet agregation that inhibits the progression of intracoronary thrombus must be optimal at the time of angioplasty to reduce the risk of thrombotic events. Intracoronary thrombus residual angiographic post-thrombolysis was associated with impaired myocardial reperfusion but coronary angiography has a very low sensitivity for detecting the thrombus. The optical coherence tomography (OCT) is currently the method of choice to visualize and quantify the intracoronary thrombus. It is used routinely in the presence of a thrombus to correctly estimate the size of the artery and for the evaluation of good stent apposition.

The thrombectomy at the time of angioplasty improves myocardial reperfusion, particularly in case of major thrombotic mass. Intracoronary thrombus residual post-thrombolysis could be a marker for the quality of reperfusion itself correlated to the quality of the antiplatelet post-thrombolysis.

The investigators therefore hypothesize that the systematic use of the OCT before elective angioplasty (within 3 to 24 hours) after successful thrombolysis could be used to guide the use of thrombectomy and adequate stenting and thus improve myocardial reperfusion. Our study will also correlate the importance of the residual thrombus before angioplasty myocardial reperfusion one hand and to the inhibition of platelet activity observed other.

Conditions

Myocardial Infarction; Intracoronary Thrombus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

optimal coherence tomography

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• acute myocardial infarction
• treated with successful fibrinolysis
• who require coronary stenting

Exclusion Criteria

• cardiogenic shock
• hemostasis disorders
• non accessible coronary lesion for OCT
• severe renal insuffisiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ROULE

Caen, , France

Countries

France

Other Identifiers

15-032

Identifier Type: -

Identifier Source: org_study_id