Clinical trial NCT04496687: International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
Official title: The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Coronary Artery Dissection
Keywords: spontaneous coronary artery dissection (SCAD)
myocardial infarction
sudden cardiac arrest
acute coronary syndrome
Lead sponsor: SCAD Alliance
Sponsor class: OTHER
Collaborators: name: PERFUSE Study Group
First posted: 2020-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spontaneous coronary artery dissection (SCAD) is defined as the non-traumatic, non-iatrogenic separation of the coronary arterial wall by intramural hemorrhage creating a false lumen, with or without an intimal tear. SCAD nearly always presents as an acute myocardial infarction. The prevalence of SCAD varies depending on the population studied. A goal of iSCAD Registry is to expand diversity of race, ethnicity, and sex of study participants. The mean age of SCAD presentation is 45-53 years of age, and appears to primarily affect women.

Brief summary: The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD.

The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.

Detailed description: Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow in the artery.

SCAD strikes generally healthy, younger individuals (average age 42) who do not have traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass the physical and psychosocial study of SCAD.

Eligibility criteria: Inclusion Criteria:

Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:

1. Inpatient wards of the enrolling medical centers during the acute presentation of SCAD, or
2. Outpatient cardiovascular clinics of enrolling medical centers.

Participants must be:

* 18 years of age or older
* Diagnosis of SCAD or history of SCAD based on coronary angiography, either catheter-based or coronary CTA
* Suspected SCAD by coronary angiography

Exclusion Criteria:

1. Coronary dissection in association with atherosclerosis or as a result of iatrogenic injury
2. Inability to provide informed consent
3. Inability to complete study-related patient questionnaires
4. Inability to understand and complete patient questionnaires independently

Primary outcomes:
measure: Descriptive Data
timeFrame: Continuous time frame following index event for an average of 3 years from study contact date
measure: Clinical Outcomes
timeFrame: Continuous time frame following index event for an average of 3 years from study contact date
measure: Psychosocial Outcomes
timeFrame: Continuous time frame following index event for an average of 3 years from study contact date
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Los Angeles
country: United States
facility: UCLA (University of California, Los Angeles)
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: St. Luke's Mid America
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health Sanger Heart and Vascular Institute
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals--Case Western
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart
state: Oklahoma
city: Portland
country: United States
facility: Providence
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital, Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Murray
country: United States
facility: Intermountain
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Inova Heart & Vascular Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medicine
state: Washington
city: Darlinghurst
country: Australia
facility: Victor Chang Cardiac Research Institute
state: New South Wales
Study officials:
affiliation: Chair, Steering Committee
name: Esther Kim, MD
role: STUDY_CHAIR
affiliation: Member, Steering Committee
name: Malissa Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Member, Steering Committee
name: Sahar Naderi, MD
role: PRINCIPAL_INVESTIGATOR
References: