Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spontaneous Coronary Artery Dissection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics): A Substudy of the INSPIRE Registry
Overview
Spontaneous coronary artery dissection (SCAD) is a rare cause of coronary ischemia and infarction where a tear in blood vessel wall either restricts the flow of blood or the blood becomes trapped in between the layers of the vessel causing the vessel to impinge on the lumen and causing an obstruction or restriction of blood flow. The ultimate goal of this proposal is to further understand the risk factors leading to SCAD with a focus on familial and genetic causes of SCAD.
Detailed description
For this study, we will ascertain clinical data and biological samples from a cohort of SCAD patients identified using retrospective review of medical records and prospective surveillance of Intermountain patients that undergo coronary angiography. The SCAD diagnosis will be based on independent review of clinical presentation, cardiac imaging, and angiography findings by two cardiologists and a third cardiologist in case of disagreement. It is anticipated that we hope to recruit 100 SCAD patients.
Enrollment of these subjects will be done under the INSPIRE registry. The subjects will be asked to sign a consent, provide biological samples, and complete questionnaires related to SCAD as part of the INSPIRE registry.
The SCAD cases will be matched to records in the Intermountain Genealogy Registry (IGR) to allow for the identification of possible high-risk SCAD families. Risk of first and second degree relatives will also be assessed. The obtained blood samples will be processed, stored and genotyped.
Primary outcome measures
- Genetic variants [Time frame: at enrollment]
Eligibility criteria
Inclusion criteria
SCAD Cases
- Subjects of all ages, gender, or race
- Subjects had coronary angiography.
- Subjects had suspected SCAD as based on clinical report.
Controls
- INSPIRE subject that had coronary angiography at Intermountain Healthcare for stable angina.
- Subjects had no or mild atherosclerotic heart disease at time of angiography.
- Age at last visit as recorded in the Intermountain EDW at least 50 years or older.
- Not screened as possibly having a SCAD or coronary artery dissection diagnosis.
Exclusion criteria
SCAD Cases
- Independent review of cardiac imaging and clinical presentation by three cardiologists determine the coronary angiography was not a result of SCAD.
- Imaging from time of coronary angiography of poor quality as to not allow for proper determination of SCAD.
- Inability to determine criteria as outlined above.
- Subjects that have had a heart transplant.
- Subjects that have had a bone marrow transplant.
- Inability or refusal of the patient and/or the patient's legally acceptable representative to provide informed consent or blood sample for any reason.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the trial.
Controls
- Subjects that have a heart transplant.
- Subjects that have a bone marrow transplant.
- Subjects with any of the following diagnosis at anytime
- Heart failure
- Heart valve disease
- Thoracic aortic aneurysm and dissection
- Ehlers-Danlos syndrome
- Shprintzen-Goldberg syndrome
- Marfan syndrome
- Loeys-Dietz aortic aneurysm syndrome
- Arterial tortuosity syndrome
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Family-based
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT03876847 · 1050343