Spontaneous Coronary Artery DissectionSCAD-INSPIRENCT03876847
Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics)
An observational study of Spontaneous Coronary Artery Dissection, run by Intermountain Health Care, Inc..
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2016to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will be Intermountain Healthcare patients. The case subjects will be SCAD patients and the control population for the genetics will be Intermountain angiography patients without SCAD.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics): A Substudy of the INSPIRE Registry
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.
Read the 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.
- Conditions
- Spontaneous Coronary Artery Dissection
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous Coronary Artery Disection | The spontaneous coronary artery disection (SCAD) diagnosis will be based on independent review of clinical presentation, cardiac imaging, and angiography findings by three cardiologists. The determination will be evidence of linear luminal defect (intimal flap) detection, luminal narrowing or occlusion confirmed to be a dissection on further imaging, or by clinical judgment classifying it as definite SCAD. | |
| Control | A set of controls will be used for genetic analysis. These controls will pulled from subjects in the INSPIRE registry that had coronary angiography at Intermountain Medical Center for stable angina and meet inclusion/exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start17 Oct 2016
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
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.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876847
- Sponsor's protocol ID
- 1050343
- Acronym
- SCAD-INSPIRE
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Spontaneous Coronary Artery Dissection (SCAD-INSPIRE Genetics): A Substudy of the INSPIRE Registry
- ClinicalTrials.gov ID
- NCT03876847
- Acronym / sponsor ID
- SCAD-INSPIRE / 1050343
- Conditions
- Spontaneous Coronary Artery Dissection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 15 Mar 2019 (actual)
- 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 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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Coronary Artery Disection | – | –The spontaneous coronary artery disection (SCAD) diagnosis will be based on independent review of clinical presentation, cardiac imaging, and angiography findings by three cardiologists. The determination will be evidence of linear luminal defect (intimal flap) detection, luminal narrowing or occlusion confirmed to be a dissection on further imaging, or by clinical judgment classifying it as definite SCAD. |
| Control | – | –A set of controls will be used for genetic analysis. These controls will pulled from subjects in the INSPIRE registry that had coronary angiography at Intermountain Medical Center for stable angina and meet inclusion/exclusion criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be Intermountain Healthcare patients. The case subjects will be SCAD patients and the control population for the genetics will be Intermountain angiography patients without SCAD.
Key inclusion criteria (9 listed)
- SCAD Cases
- Subjects of all ages, gender, or race
- Subjects had coronary angiography.
- Subjects had suspected SCAD as based on clinical report.
- Controls
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic variants
Time frame: at enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Coronary Artery Dissection, run by Intermountain Health Care, Inc..
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 9 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Genetic variants (time frame: at enrollment). 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 14 Apr 2026.