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Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

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ClinicalTrials.gov Identifier: NCT01427179
Recruitment Status : Recruiting
First Posted : September 1, 2011
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy M. Olson, M.D., Mayo Clinic

Brief Summary:

The purpose of the research is to identify mutations (defects in the genetic blueprint) that cause spontaneous coronary artery dissection (SCAD), in other words, spontaneous tears in blood vessels that supply the heart.

Some mutations may be inherited (passed on) from a parent without an apparent blood vessel problem while others may develop for the first time in the affected person.


Condition or disease
Spontaneous Coronary Artery Dissection SCAD

Detailed Description:

Study question: Do mutations within certain genes cause or confer susceptibility to spontaneous coronary artery dissection (SCAD)?

Specific aims:

  1. Create a genomic DNA and plasma biobank for individuals diagnosed with SCAD.
  2. Identify inherited and de novo/new mutations that underlie SCAD.

Long term objective:Discover molecular and cellular mechanisms of SCAD and develop biomarkers to enable prediction and prevention.

The purpose of the research is to identify mutations (defects in the genetic blueprint) that cause tears in blood vessels that supply the heart. Some mutations may be inherited (passed on) from a parent without an apparent blood vessel problem while others may develop for the first time in the affected person. The study includes individuals diagnosed with spontaneous coronary artery dissection and their biological parents.

Adults with SCAD will be identified both retrospectively and prospectively.Confirmation of the diagnosis by review of coronary angiography will be required before proceeding with the informed consent process and blood or saliva sample procurement.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Family-Based
Time Perspective: Other
Official Title: Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)
Study Start Date : May 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Identification of one or more gene mutation responsible for SCAD [ Time Frame: By end of study ]

Biospecimen Retention:   Samples With DNA
A 30 ml sample of blood from a vein or an existing catheter will be drawn at Mayo Clinic or another medical center and returned through the mail in a kit. Alternatively, a saliva sample will be collected and returned through the mail in a kit. An additional 10 ml (2 teaspoons) of blood, buccal smear, and/or available tissue samples may also be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women diagnosed with spontaneous coronary artery dissection (SCAD) or and their biological parents.
Criteria

Inclusion Criteria:

  • Men and women able to give informed consent and complete a 2 page questionnaire
  • Diagnosis of one or more episodes of spontaneous coronary artery dissection (SCAD)
  • Biological parent of individual with SCAD

Exclusion Criteria:

  • Lack of confirmation of SCAD diagnosis

Information from the National Library of Medicine

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): NCT01427179


Contacts
Contact: Jill Boyum 507-266-3180 MayoSCAD@Mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Boyum    507-266-3180    mayoscad@mayo.edu   
Principal Investigator: Timothy M. Olson, M.D.         
Principal Investigator: Sharonne N. Hayes, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Timothy M. Olson, M.D. Mayo Clinic
Principal Investigator: Sharonne N. Hayes, M.D. Mayo Clinic

Additional Information:
Publications:
Responsible Party: Timothy M. Olson, M.D., Professor of Pediatrics and Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01427179     History of Changes
Other Study ID Numbers: 11-000160
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by Timothy M. Olson, M.D., Mayo Clinic:
Spontaneous coronary artery dissection
SCAD

Additional relevant MeSH terms:
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases