Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD (SCAD)

• ClinicalTrials.gov Identifier: NCT03390998
• Recruitment Status: Completed
• First Posted: January 5, 2018
• Last Update Posted: September 25, 2019
• Sponsor: Katharine Sears Edwards
• Collaborators: Massachusetts General Hospital; Mayo Clinic; University Hospital, Clermont-Ferrand; University of British Columbia; University of Leicester; Vanderbilt University Medical Center
• Information provided by (Responsible Party): Katharine Sears Edwards, Stanford University

Study Description

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.

Condition or disease
Spontaneous Coronary Artery Dissection

Detailed Description:

There is a reason to believe that female sex hormone fluctuations during the peripartum period are linked with the occurrence of SCAD, and may be associated with a distinctive clinical presentation. In addition, symptoms of psychological distress may be linked to the development of SCAD and post-event distress is higher in SCAD patients than in those with coronary artery disease (CAD).

The primary objective is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients. At the methodological level, the purpose is to apply a systematic image analysis protocol for classifying SCAD lesions and to pool data to achieve adequate statistical power.

The secondary objective is to gather more information about psychological and psychosocial factors in SCAD patients. Specifically, to assess pre-event stress and psychological diagnoses and determine differences in post-event distress between peripartum and non-peripartum SCAD.

It is expected that these aims will result in two important outcomes. First, implementation of a systematic image analysis protocol for SCAD data will lead to improved reliability and, we expect, the detection of clinically meaningful differences between peripartum and non-peripartum SCAD. These differences may align with potential causal mechanisms for further study to ultimately better understand SCAD and develop treatment(s). Second, by characterizing the psychological distress experienced by SCAD patients, and differences between patients who experienced peripartum vs. non-peripartum SCAD, psychosocial risk factors may be identified and psychosocial interventions can be tailored to meet the needs of this unique patient population.

This is an observational study using cross-sectional design. There are two main components: a retrospective collection of medical history pertaining to SCAD event and prospective questionnaires. Sites may elect not to contact patients and not collect the prospective questionnaire.

Clinical variables will include demographic data, cardiac risk factors, medications and details of presentation (including peak troponin, left ventricular ejection fraction (LVEF), and days to discharge), as well as follow-up data, including recurrent events, and symptoms of depression, anxiety, stress, and PTSD.

Clinical data will be obtained by study collaborators and entered into a secure database maintained on Stanford systems. De-identified imaging data will be uploaded by collaborators. Imaging data will be analyzed by two independent readers (selected from participating institutions).

Study Design

• Study Type: Observational
• Actual Enrollment: 241 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD): A Collaborative Study
• Actual Study Start Date: November 28, 2017
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

1. First Major Adverse Cardiovascular Event (post-SCAD) [ Time Frame: 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. ]
   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.

Secondary Outcome Measures :

1. Depression [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
   Patient Health Questionnaire (PHQ9) is a 9-item questionnaire that measures depression on a scale of 0-27 (where >20 is major depression).
2. Anxiety [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
   Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that measures anxiety on a scale of 0-21 (where >14 is severe anxiety).
3. Stress [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
   Perceived Stress Scale (PSS) is a 10-item questionnaire that measures stress on a scale of 0-40 (where >26 is high perceived stress).
4. Post-Traumatic Stress Disorder [ Time Frame: At survey administration (post-SCAD), ranging from 6-months to 10 years post SCAD. ]
   PTSD CheckList (PCL-5) is a 20-item questionnaire that assesses the presence and severity of PTSD symptoms on a scale of 0-80 (where >32 suggests the patients needs further assessment to confirm a diagnosis of PTSD).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only women will be studied as the primary question relates to pregnancy-related SCAD
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria

- Not fulfilling inclusion criteria

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94305

Sponsors and Collaborators

Katharine Sears Edwards

Massachusetts General Hospital

Mayo Clinic

University Hospital, Clermont-Ferrand

University of British Columbia

University of Leicester

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Jennifer Ann Tremmel, MD, MS; Stanford University
• Principal Investigator: Katharine S. Edwards, PhD; Stanford University

More Information

• Responsible Party: Katharine Sears Edwards, Clinical Assistant Professor, Medicine - Cardiovascular Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT03390998
• Other Study ID Numbers: 40486
• First Posted: January 5, 2018
• Last Update Posted: September 25, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katharine Sears Edwards, Stanford University:

Pregnancy-related SCAD; Myocardial Infarction

Additional relevant MeSH terms:

Coronary Vessel Anomalies; Vascular Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities