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OpenTrials
Completed

NCT Number: NCT02850315

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ROULE

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optimal coherence tomography

Device

Primary outcomes

  1. myocardial reperfusion of systematic guidance measured by OCT of the angioplasty procedure

    Time frame: baseline

    in patients treated with thrombolysis and requiring the establishment of a stent

Secondary outcomes

  1. volume of thrombus messured by OCT before angioplasty

    Time frame: 24hours

  2. inhibition of platelet activity evaluated by aggregometry

    Time frame: 24hours

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: AODIS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2016
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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