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

Myocardial Infarction Clinical Trial

— AODIS  

Official title:

Assessment Of Intracoronary Thrombus By Optical Frequency Domain Imaging During Percutaneous Coronary Intervention After Successful Fibrinolysis And Its Impact On Myocardial Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850315
• Other study ID #: 15-032
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: August 16, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Intracoronary Thrombus
• Myocardial Infarction
• Thrombosis

Intervention

Device:
• optimal coherence tomography

Locations

Country	Name	City	State
France	ROULE	Caen Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial reperfusion of systematic guidance measured by OCT of the angioplasty procedure	in patients treated with thrombolysis and requiring the establishment of a stent	baseline
Secondary	volume of thrombus messured by OCT before angioplasty		24hours
Secondary	inhibition of platelet activity evaluated by aggregometry		24hours