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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| Tracking Information | ||||||||||
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| First Submitted Date | July 29, 2020 | |||||||||
| First Posted Date | August 3, 2020 | |||||||||
| Last Update Posted Date | August 21, 2023 | |||||||||
| Actual Study Start Date | March 8, 2019 | |||||||||
| Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry | |||||||||
| Official Title | The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD) | |||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | 3 Years | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Spontaneous coronary artery dissection (SCAD) is defined as the non-traumatic, non-iatrogenic separation of the coronary arterial wall by intramural hemorrhage creating a false lumen, with or without an intimal tear. SCAD nearly always presents as an acute myocardial infarction. The prevalence of SCAD varies depending on the population studied. A goal of iSCAD Registry is to expand diversity of race, ethnicity, and sex of study participants. The mean age of SCAD presentation is 45-53 years of age, and appears to primarily affect women. | |||||||||
| Condition | Spontaneous Coronary Artery Dissection | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
1000 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | December 31, 2025 | |||||||||
| Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria: Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:
Participants must be:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | Australia, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT04496687 | |||||||||
| Other Study ID Numbers | 20190308 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | SCAD Alliance | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | SCAD Alliance | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | PERFUSE Study Group | |||||||||
| Investigators |
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| PRS Account | SCAD Alliance | |||||||||
| Verification Date | August 2023 | |||||||||