Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD

NCT03390998 | Completed

• 1 other identifier: 40486
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-site international clinical research project is a collaboration between investigators from multiple institutions in the USA, Canada, and Europe. Approximately 7 to 11 sites will participate and provide data for analysis. Clinical operations (for data collection and analysis) across sites will be managed by Stanford. The study purpose is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peripartum and non-peripartum SCAD patients.

Conditions

Spontaneous Coronary Artery Dissection

Keywords

Pregnancy-related SCAD; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• First Major Adverse Cardiovascular Event (post-SCAD)

  The time from the first SCAD event until the first occurrence of (1) myocardial infarction, (2) re-vascularization, (3) stroke, or (4) death due to cardiovascular cause.

  First SCAD event represents t=0. Time (in days) from t=0 until the first occurrence of any of the above, for up to 6-months after t=0.

Secondary Outcomes (4)

• Depression

  At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.

• Anxiety

  At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.

• Stress

  At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.

• Post-Traumatic Stress Disorder

  At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD.

Study Arms (2)

Peripartum SCAD

Female patients who experienced any SCAD event that occurred during pregnancy or up to 1 year post-delivery

Non-peripartum SCAD

Female patients who experienced any SCAD with event onset outside of the pregnancy period

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women will be studied as the primary question relates to pregnancy-related SCAD
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with pregnancy-related and non pregnancy-related SCAD will be recruited from the population of SCAD patients known to an international collaborative of investigators. We expect to enroll approximately 400 patients, 100 of whom have experienced peripartum SCAD. For each enrolled participant with peripartum SCAD, we will enroll 3 patients with non-peripartum SCAD who are the closest match on age at SCAD event and country.

You may qualify if:

• Sites contacting patients and/or conducting the survey
• Female adults 18 years of age and older
• Voluntary participation
• Patients with a known or suspected diagnosis of SCAD
• Ability to read in English
• Ability to access online consent and questionnaire portal
• Sites not contacting patients and/or conducting the survey
• Female adults 18 years of age and older
• Patients with a known or suspected diagnosis of SCAD

Sponsors & Collaborators

• Katharine Sears Edwards: lead
• Massachusetts General Hospital: collaborator
• Mayo Clinic: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• University of British Columbia: collaborator
• University of Leicester: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jennifer Ann Tremmel, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

• Katharine S. Edwards, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor, Medicine - Cardiovascular Medicine

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 5, 2018
• Study Start: November 28, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)