Myocardial InfarctionAODISNCT02850315
Intracoronary Thrombus Assessed by OFDI After Successful Fibrinolysis And Its Impact On Myocardial Reperfusion
An observational study of Myocardial Infarction and Intracoronary Thrombus, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Intracoronary Thrombus
- What is being tested?
- optimal coherence tomography
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with acute myocardial infarction treated by successful fibrininolysis and who requires a coronary stenting
Who may be able to join
- acute myocardial infarction
- treated with successful fibrinolysis
- who require coronary stenting
Who cannot join
- cardiogenic shock
- hemostasis disorders
- non accessible coronary lesion for OCT
- severe renal insuffisiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Intracoronary Thrombus By Optical Frequency Domain Imaging During Percutaneous Coronary Intervention 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.
- Conditions
- Myocardial Infarction, Intracoronary Thrombus
- Being tested
- optimal coherence tomography
- Keywords
- optimal coherence tomography, myocardial reperfusion
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimal coherence tomographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial reperfusion of systematic guidance measured by OCT of the angioplasty procedure
in patients treated with thrombolysis and requiring the establishment of a stent
Measured: baseline
Secondary outcomes (2)
volume of thrombus messured by OCT before angioplasty
Measured: 24hours
inhibition of platelet activity evaluated by aggregometry
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850315
- Sponsor's protocol ID
- 15-032
- Acronym
- AODIS
- Status last verified
- Jan 2017
- First submitted
- 12 Jul 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Intracoronary Thrombus By Optical Frequency Domain Imaging During Percutaneous Coronary Intervention After Successful Fibrinolysis And Its Impact On Myocardial Reperfusion
- ClinicalTrials.gov ID
- NCT02850315
- Acronym / sponsor ID
- AODIS / 15-032
- Conditions
- Myocardial Infarction, Intracoronary Thrombus
- Keywords
- optimal coherence tomography, myocardial reperfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with acute myocardial infarction treated by successful fibrininolysis and who requires a coronary stenting
Key inclusion criteria (3 listed)
- acute myocardial infarction
- treated with successful fibrinolysis
- who require coronary stenting
Key exclusion criteria (4 listed)
- cardiogenic shock
- hemostasis disorders
- non accessible coronary lesion for OCT
- severe renal insuffisiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optimal coherence tomography | Device | – |
Primary outcome
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
2 secondary outcomes
volume of thrombus messured by OCT before angioplasty
Time frame: 24hours
inhibition of platelet activity evaluated by aggregometry
Time frame: 24hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Intracoronary Thrombus, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial reperfusion of systematic guidance measured by OCT of the angioplasty procedure (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.