Spontaneous Coronary Artery DissectionDISCONCT02799186
The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.
A study testing blood sample for genetic analysis in people with Spontaneous Coronary Artery Dissection and Spontaneous Coronary Artery Haematoma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Coronary Artery Dissection, Spontaneous Coronary Artery Haematoma
- What is being tested?
- blood sample for genetic analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 4 Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients over 18 year's old
- Patient with a possible diagnosis of spontaneous coronary dissection defined by:
- A picture of SCA
- Compatible angiographic signs
- More or less confirmed by intracoronary imaging (OCT/IVUS) or check angiographic control (upper to 1 month)
- Patient having given his informed consent and signed to participate to the study
- Subject accepting the use of its personal data in the form of an anonymous codification including in the scientific publications.
Who cannot join
- - Minor patient
- Major patient submitted to a protective measure (guardianship, supervision guardianship)
- No affiliation to the French social security system
- Coronary dissection with traumatic or iatrogenic origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.
The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection.
Read more
From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis.
For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected.
This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge.
Read the detailed description
The recruitment of patients takes place in each interventional cardiology department.
The patients can be included in a retrospective way (for SCAD occurred from 2010) or forward-looking way. The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed.
Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France.
- Being tested
- blood sample for genetic analysis
- Keywords
- Spontaneous Coronary Artery Dissection, haematoma, Fibromuscular Dysplasia, genetic analysis, Acute Coronary Syndrome
- Medical subject headings
- Coronary Artery Dissection, Spontaneous, Hematoma, Fibromuscular Dysplasia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample for genetic analysisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SCAD (spontaneous coronary artery dissection) | Experimental | Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France. Receives: Procedure: blood sample for genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the SCAD in the population of patients taken care for a ACS
Measured: at day 1
Secondary outcomes (5)
Prevalence of the FMD in the population SCAD from a tomographic or MRI angiography analysis of renal, cerebrovascular and iliac arteries
Measured: at day 1
Hormonal Parameters ( gynecological factors)
Measured: at day 1
Environmental Factors : physical exercise or an recent intense emotional stress
Measured: at day 1
Genetic Factors (including recently identified genetic risk loci for FMD)
Measured: at day 1
Morbi-mortality to 1 year
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Research Foundation, French Coronary Atheroma and Interventional Cardiology Group
- Responsible party
- Sponsor
- Investigators
- Pascal MOTREFF, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799186
- Sponsor's protocol ID
- CHU-0267
- Other IDs
- 2016-A00403-48
- Acronym
- DISCO
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2016
- Last updated
- 3 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION
- ClinicalTrials.gov ID
- NCT02799186
- Acronym / sponsor ID
- DISCO / CHU-0267
- Keywords
- Spontaneous Coronary Artery Dissection, haematoma, Fibromuscular Dysplasia, genetic analysis, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Heart and Research Foundation, French Coronary Atheroma and Interventional Cardiology Group
- Study start
- May 2016
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 14 Jun 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.
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.
The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection.
From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis.
For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected.
This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge.
Detailed description
The recruitment of patients takes place in each interventional cardiology department.
The patients can be included in a retrospective way (for SCAD occurred from 2010) or forward-looking way. The patients are informed about this study by the investigator. After a reflection period and an answer to the possible questions, the patient is included. The informed consent is signed.
Every patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCAD (spontaneous coronary artery dissection) | Experimental | Procedure: blood sample for genetic analysisEvery patient included with a SCAD or hematoma, will systematic benefit a tomographic or MRI angiography of renal, cerebrovascular and iliac arteries, to look for the presence of a fibromuscular displasia. A blood sample will be collected for the genetic analysis which will be realized by the Team 3 of the INSERM UMR970, Paris Cardiovascular research Center, France. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 year's old
- Patient with a possible diagnosis of spontaneous coronary dissection defined by:
- Patient having given his informed consent and signed to participate to the study
- Subject accepting the use of its personal data in the form of an anonymous codification including in the scientific publications.
Key exclusion criteria (4 listed)
- - Minor patient
- Major patient submitted to a protective measure (guardianship, supervision guardianship)
- No affiliation to the French social security system
- Coronary dissection with traumatic or iatrogenic origin
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 |
|---|---|---|
| blood sample for genetic analysis | Procedure or surgery | SCAD (spontaneous coronary artery dissection) |
Primary outcome
Incidence of the SCAD in the population of patients taken care for a ACS
Time frame: at day 1
5 secondary outcomes
Prevalence of the FMD in the population SCAD from a tomographic or MRI angiography analysis of renal, cerebrovascular and iliac arteries
Time frame: at day 1
Hormonal Parameters ( gynecological factors)
Time frame: at day 1
Environmental Factors : physical exercise or an recent intense emotional stress
Time frame: at day 1
Genetic Factors (including recently identified genetic risk loci for FMD)
Time frame: at day 1
Morbi-mortality to 1 year
Time frame: at 1 year
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 3 Aug 2026.
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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.
Pascal MOTREFF principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample for genetic analysis in people with Spontaneous Coronary Artery Dissection and Spontaneous Coronary Artery Haematoma, run by University Hospital, Clermont-Ferrand 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 7 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 3 Aug 2026. 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?
Incidence of the SCAD in the population of patients taken care for a ACS (time frame: at day 1). 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 3 Aug 2026.