International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
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| ClinicalTrials.gov Identifier: NCT04496687 |
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Recruitment Status :
Recruiting
First Posted : August 3, 2020
Last Update Posted : August 21, 2023
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The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD.
The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.
| Condition or disease |
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| Spontaneous Coronary Artery Dissection |
Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow in the artery.
SCAD strikes generally healthy, younger individuals (average age 42) who do not have traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass the physical and psychosocial study of SCAD.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD) |
| Actual Study Start Date : | March 8, 2019 |
| Estimated Primary Completion Date : | December 31, 2025 |
| Estimated Study Completion Date : | December 31, 2025 |
- Descriptive Data [ Time Frame: Continuous time frame following index event for an average of 3 years from study contact date ]Participant demographic, historical, clinical characteristics, and treatment data
- Clinical Outcomes [ Time Frame: Continuous time frame following index event for an average of 3 years from study contact date ]Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality
- Psychosocial Outcomes [ Time Frame: Continuous time frame following index event for an average of 3 years from study contact date ]Prospectively collected data on participant's mental health using validated questionnaires
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:
- Inpatient wards of the enrolling medical centers during the acute presentation of SCAD, or
- Outpatient cardiovascular clinics of enrolling medical centers.
Participants must be:
- 18 years of age or older
- Diagnosis of SCAD or history of SCAD based on coronary angiography, either catheter-based or coronary CTA
- Suspected SCAD by coronary angiography
Exclusion Criteria:
- Coronary dissection in association with atherosclerosis or as a result of iatrogenic injury
- Inability to provide informed consent
- Inability to complete study-related patient questionnaires
- Inability to understand and complete patient questionnaires independently
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496687
| Contact: Esther Kim, MD, MPH | 704-373-0212 | Soo.Kim@atriumhealth.org |
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| Study Chair: | Esther Kim, MD | Chair, Steering Committee | |
| Principal Investigator: | Malissa Wood, MD | Member, Steering Committee | |
| Principal Investigator: | Sahar Naderi, MD | Member, Steering Committee |
| Responsible Party: | SCAD Alliance |
| ClinicalTrials.gov Identifier: | NCT04496687 |
| Other Study ID Numbers: |
20190308 |
| First Posted: | August 3, 2020 Key Record Dates |
| Last Update Posted: | August 21, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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spontaneous coronary artery dissection (SCAD) myocardial infarction sudden cardiac arrest acute coronary syndrome |
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Aortic Dissection Coronary Vessel Anomalies Vascular Diseases Dissection, Blood Vessel Aneurysm Cardiovascular Diseases |
Acute Aortic Syndrome Aortic Diseases Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |