Trial record 3 of 7 for:    Open Studies | "Aneurysm, Dissecting"

The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Sharonne Hayes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01429727
First received: August 30, 2011
Last updated: May 30, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 2017
Estimated Primary Completion Date: December 2016 (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
Study Population

Men and women with spontaneous coronary artery dissection (SCAD) as confirmed on angiogram.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429727

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: Sharonne N. Hayes, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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 30, 2014
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 July 20, 2014