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NCT Number: NCT02799186

The Study of the Prevalence Fibromuscular Dysplasia in Patient 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.

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.

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Key information

Conditions

Spontaneous Coronary Artery Dissection Acute Coronary Syndrome Arterial Occlusive Diseases Cardiovascular Diseases Coronary Artery Dissection, Spontaneous Fibromuscular Dysplasia Heart Diseases Hematoma Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Spontaneous Coronary Artery Haematoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

blood sample for genetic analysis

Procedure

Primary outcomes

  1. Incidence of the SCAD in the population of patients taken care for a ACS

    Time frame: at day 1

Secondary outcomes

  1. 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

  2. Hormonal Parameters ( gynecological factors)

    Time frame: at day 1

  3. Environmental Factors : physical exercise or an recent intense emotional stress

    Time frame: at day 1

  4. Genetic Factors (including recently identified genetic risk loci for FMD)

    Time frame: at day 1

  5. Morbi-mortality to 1 year

    Time frame: at 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • French Coronary Atheroma and Interventional Cardiology Group
  • Heart and Research Foundation

Registry information

Official study title

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

Acronym: DISCO

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2016
Registry last updated
Jan 24, 2022

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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