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Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

This study is currently recruiting participants.
Verified May 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Sharonne Hayes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01427179
First received: August 30, 2011
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Spontaneous Coronary Artery Dissection
SCAD

Study Type: Observational
Study Design: Observational Model: Family-Based
Official Title: Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Identification of one or more gene mutation responsible for SCAD [ Time Frame: By end of study ] [ Designated as safety issue: No ]

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. An additional 10 ml (2 teaspoons) of blood, buccal smear, and/or available tissue samples may also be collected.


Estimated Enrollment: 600
Study Start Date: May 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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 sample procurement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427179

Contacts
Contact: Jill Boyum 507-266-3180 MayoSCAD@Mayo.edu
Contact: Matt Hoplin 507-284-9482 hoplin.matt@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jill Boyum     507-255-0473     mayoscad@mayo.edu    
Contact: Matt Hoplin     507-284-9482     hoplin.matt@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
  More Information

Additional Information:
Mayo Clinic SCAD Blog for downloading study forms  This link exits the ClinicalTrials.gov site
Patient information on spontaneous coronary artery dissection  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sharonne Hayes, Professor, Cardiovascular Diseases, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01427179     History of Changes
Other Study ID Numbers: 11-000160
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

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

ClinicalTrials.gov processed this record on May 22, 2013