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Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01427179
Recruitment Status : Enrolling by invitation
First Posted : September 1, 2011
Last Update Posted : July 31, 2020
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.
  3. Identify common genetic variants that confer risk for 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, their biological parents, and relatives with fibromuscular dysplasia, arterial aneurysm, or arterial dissection.

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.

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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





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

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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), their biological parents, and relatives with fibromuscular dysplasia, arterial aneurysm, or arterial dissection.
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
  • Relative with fibromuscular dysplasia, arterial aneurysm, or arterial dissection

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


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Timothy M. Olson, M.D. Mayo Clinic
Principal Investigator: Sharonne N. Hayes, M.D. Mayo Clinic
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Timothy M. Olson, M.D., Professor of Pediatrics and Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01427179    
Other Study ID Numbers: 11-000160
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by Timothy M. Olson, M.D., Mayo Clinic:
Spontaneous coronary artery dissection
SCAD
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases