The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry (SCAD)
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|ClinicalTrials.gov Identifier: NCT01429727|
Recruitment Status : Recruiting
First Posted : September 7, 2011
Last Update Posted : March 22, 2017
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.
A prospective sub-study of echocardiographic findings after SCAD that includes perfusion imaging (Lumason contrast) is available to patients who are evaluated at Mayo Clinic, Rochester, MN. A separate consent process is included as part of this sub-study.
|Condition or disease|
|Spontaneous Coronary Artery Dissection SCAD|
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.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2025|
Individuals who have experienced at least one episode of spontaneous coronary artery dissection.
- Descriptive Data [ Time Frame: Continuous time frame following index event for an average of 2 years from study contact date. ]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. ]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. ]Record update on patient's current mental health status since the initial SCAD event.
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): NCT01429727
|Contact: Jill Boyumemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Jill Boyum 507-266-3180 firstname.lastname@example.org|
|Principal Investigator: Sharonne N. Hayes, M.D.|
|Principal Investigator:||Sharonne N. Hayes, M.D.||Mayo Clinic|