The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry
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Purpose
The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event.
This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.
| Condition |
|---|
|
Spontaneous Coronary Artery Dissection SCAD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry |
- Descriptive Data [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]Obtain data regarding SCAD related risk factors, presenting characteristics, treatments and long term outcomes.
- Physical Health Update [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]Record update on patient's current physical health and any relevant health events that may have occurred since the initial SCAD event.
- Mental Health Update [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ] [ Designated as safety issue: No ]Record update on patient's current mental health status since the initial SCAD event.
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
SCAD Registry
Individuals who have experienced at least one episode of spontaneous coronary artery dissection.
|
Detailed Description:
Spontaneous Coronary Artery Dissection (SCAD) is a relatively rare and poorly understood condition that has been reported to affect more women than men. The coronary arteries consist of three layers, and dissection occurs when two of these layers separate, enabling blood to flow into the space between the layers. As the blood accumulates, this can cause obstruction to normal blood flow within the heart, leading to chest pain, heart attack and even sudden death.
The medical community has much to learn about treatment and prevention of this potentially fatal cardiovascular event. Mayo Clinic is conducting two new studies of SCAD. This study consists of building a database/registry of patients with SCAD (whether they have been patients at Mayo Clinic or not) to identify patterns of SCAD incidence, causes and associations that could guide future research. With participant consent, Mayo Clinic staff will request a copy of the original coronary angiogram when SCAD was diagnosed to confirm the diagnosis and determine eligibility. If eligible, study coordinators will contact the participant to provide more information about the studies and request a signed informed consent document.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Men and women with spontaneous coronary artery dissection (SCAD) as confirmed on angiogram.
Inclusion Criteria:
- Men and women able to give informed consent
- Diagnosis of one or more episodes of spontaneous coronary artery dissection (SCAD)
Exclusion Criteria:
- Lack of angiographic confirmation of SCAD
- Iatrogenic dissection or an alternate diagnosis
Contacts and Locations| Contact: Jill Boyum | 507-266-3180 | mayoscad@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Jill Boyum 507-266-3180 mayoscad@mayo.edu | |
| Principal Investigator: Sharonne N. Hayes, M.D. | |
| Principal Investigator: | Sharonne N. Hayes, M.D. | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sharonne Hayes, Principal Investigator, Professor, Cardiovascular Diseases, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01429727 History of Changes |
| Other Study ID Numbers: | 11-001852 |
| Study First Received: | August 30, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Spontaneous coronary artery dissection SCAD coronary artery disease myocardial infarction coronary dissection |
Additional relevant MeSH terms:
|
Aneurysm, Dissecting Aneurysm Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013