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Recruiting NCT01429727

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

— Observational Spontaneous Coronary Artery Dissection SCAD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spontaneous Coronary Artery Dissection, SCAD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 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.

Primary outcome measures

  • Descriptive Data [Time frame: Continuous time frame following index event for 2-10 years from study contact date.]
Secondary outcome measures (2)
  • Physical Health Update [Time frame: Continuous time frame following index event for 2-10 years from study contact date.]
  • Mental Health Update [Time frame: Continuous time frame following index event for 2-10 years from study contact date.]

Eligibility criteria

Inclusion criteria

  • Individuals who have been cared for at Mayo Clinic with a diagnosis of SCAD
  • SCAD in women who are pregnant or within 12 months postpartum at the time of SCAD
  • SCAD in individuals who self-identify as a member of a racial or ethnic group that is currently underrepresented in the registry. This would include anyone who identifies as: Black/African American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and any race with Hispanic ethnicity
  • SCAD in a man
  • SCAD in persons younger than 30 years of age
  • SCAD within the past 2 weeks (acute)
  • SCAD patient enrolling into any other Mayo Clinic SCAD Research Study
  • SCAD in individuals who have a relative that has had a SCAD event

Persons with history of SCAD who are interested in participating in the study but do not meet the updated inclusion criteria will not be enrolled at this time. However, they will be given the option to share their contact information in order to be invited to future Mayo Clinic SCAD studies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Publications

  • Tweet MS, Gulati R, Aase LA, Hayes SN. Spontaneous coronary artery dissection: a disease-specific, social networking community-initiated study. Mayo Clin Proc. 2011 Sep;86(9):845-50. doi: 10.4065/mcp.2011.0312. PMID 21878595
  • Tweet MS, Hayes SN, Pitta SR, Simari RD, Lerman A, Lennon RJ, Gersh BJ, Khambatta S, Best PJ, Rihal CS, Gulati R. Clinical features, management, and prognosis of spontaneous coronary artery dissection. Circulation. 2012 Jul 31;126(5):579-88. doi: 10.1161/CIRCULATIONAHA.112.105718. Epub 2012 Jul 16. PMID 22800851
  • Tweet MS, Gulati R, Williamson EE, Vrtiska TJ, Hayes SN. Multimodality Imaging for Spontaneous Coronary Artery Dissection in Women. JACC Cardiovasc Imaging. 2016 Apr;9(4):436-50. doi: 10.1016/j.jcmg.2016.01.009. PMID 27056163
  • Krittanawong C, Tweet MS, Hayes SE, Bowman MJ, Gulati R, Squires RW, Hayes SN. Usefulness of Cardiac Rehabilitation After Spontaneous Coronary Artery Dissection. Am J Cardiol. 2016 May 15;117(10):1604-1609. doi: 10.1016/j.amjcard.2016.02.034. Epub 2016 Mar 2. PMID 27055757
  • Henkin S, Negrotto SM, Tweet MS, Kirmani S, Deyle DR, Gulati R, Olson TM, Hayes SN. Spontaneous coronary artery dissection and its association with heritable connective tissue disorders. Heart. 2016 Jun 1;102(11):876-81. doi: 10.1136/heartjnl-2015-308645. Epub 2016 Feb 10. PMID 26864667
  • Tweet MS, Gulati R, Hayes SN. What Clinicians Should Know Alphabout Spontaneous Coronary Artery Dissection. Mayo Clin Proc. 2015 Aug;90(8):1125-30. doi: 10.1016/j.mayocp.2015.05.010. PMID 26250728
  • Prasad M, Tweet MS, Hayes SN, Leng S, Liang JJ, Eleid MF, Gulati R, Vrtiska TJ. Prevalence of extracoronary vascular abnormalities and fibromuscular dysplasia in patients with spontaneous coronary artery dissection. Am J Cardiol. 2015 Jun 15;115(12):1672-7. doi: 10.1016/j.amjcard.2015.03.011. Epub 2015 Mar 23. PMID 25929580
  • Tweet MS, Hayes SN, Gulati R, Rose CH, Best PJ. Pregnancy after spontaneous coronary artery dissection: a case series. Ann Intern Med. 2015 Apr 21;162(8):598-600. doi: 10.7326/L14-0446. No abstract available. PMID 25894037

Identifiers

NCT: NCT01429727 · 11-001852

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗