The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.

Spontaneous Coronary Artery Dissection Clinical Trial

— DISCO  

Official title:

PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799186
• Other study ID #: CHU-0267
• Secondary ID: 2016-A00403-48
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 4, 2019

Study information

• Verified date: June 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria :

• 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.

Exclusion Criteria:

• - 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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Coronary Vessel Anomalies
• Fibromuscular Dysplasia
• Hematoma
• Spontaneous Coronary Artery Dissection
• Spontaneous Coronary Artery Haematoma
• Vascular Diseases

Intervention

Procedure:
• blood sample for genetic analysis

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	French Coronary Atheroma and Interventional Cardiology Group, Heart and Research Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the SCAD in the population of patients taken care for a ACS		at day 1
Secondary	Prevalence of the FMD in the population SCAD from a tomographic or MRI angiography analysis of renal, cerebrovascular and iliac arteries		at day 1
Secondary	Hormonal Parameters ( gynecological factors)		at day 1
Secondary	Environmental Factors : physical exercise or an recent intense emotional stress		at day 1
Secondary	Genetic Factors (including recently identified genetic risk loci for FMD)		at day 1
Secondary	Morbi-mortality to 1 year		at 1 year