Spontaneous Coronary Artery Dissection Clinical Trial
— SCAD-INSPIREOfficial title:
Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics): A Substudy of the INSPIRE Registry
Verified date | May 2024 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 31, 2036 |
Est. primary completion date | December 31, 2036 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: SCAD Cases 1. Subjects of all ages, gender, or race 2. Subjects had coronary angiography. 3. Subjects had suspected SCAD as based on clinical report. Controls 1. INSPIRE subject that had coronary angiography at Intermountain Healthcare for stable angina. 2. Subjects had no or mild atherosclerotic heart disease at time of angiography. 3. Age at last visit as recorded in the Intermountain EDW at least 50 years or older. 4. Not screened as possibly having a SCAD or coronary artery dissection diagnosis. Exclusion Criteria: SCAD Cases 1. Independent review of cardiac imaging and clinical presentation by three cardiologists determine the coronary angiography was not a result of SCAD. 2. Imaging from time of coronary angiography of poor quality as to not allow for proper determination of SCAD. 3. Inability to determine criteria as outlined above. 4. Subjects that have had a heart transplant. 5. Subjects that have had a bone marrow transplant. 6. Inability or refusal of the patient and/or the patient's legally acceptable representative to provide informed consent or blood sample for any reason. 7. 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 1. Subjects that have a heart transplant. 2. Subjects that have a bone marrow transplant. 3. Subjects with any of the following diagnosis at anytime 1. Heart failure 2. Heart valve disease 3. Thoracic aortic aneurysm and dissection 4. Ehlers-Danlos syndrome 5. Shprintzen-Goldberg syndrome 6. Marfan syndrome 7. Loeys-Dietz aortic aneurysm syndrome 8. Arterial tortuosity syndrome |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Intermountain Health Care, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Genetic variants | To determine genetic variants among spontaneous coronary artery dissection (SCAD) patients, we will do genotyping including target sequencing and whole exome/genome sequencing on samples provided by SCAD patients. The primary focus of this sequencing will be to determine rates of variants in genes that cause cardiac-related connective tissue disorders. | at enrollment |
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