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CompletedNCT02850315AODISUpdated Aug 18, 2017

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

An observational study in Myocardial Infarction and Intracoronary Thrombus, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-18.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
29
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction
  • Intracoronary Thrombus

Keywords

  • optimal coherence tomography
  • myocardial reperfusion
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 29 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient with acute myocardial infarction treated by successful fibrininolysis and who requires a coronary stenting

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cardiogenic shock
  • hemostasis disorders
  • non accessible coronary lesion for OCT
  • severe renal insuffisiency
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
29 participants (actual)
Patient registry
No

Interventions

  • Deviceoptimal coherence tomography
06

What researchers measure

Primary outcomes

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

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

    Time frame: baseline

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

07

Study locations

1 site
  • ROULE
    Caen Cedex 9, 14033, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02850315
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Aug 1, 2016
Start date
Jul 2015
Primary completion
May 2017
Completion
May 2017
Last update
Aug 18, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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