SCAD Clinical Trial - Canadian SCAD Study

Status Recruiting

Clinical Trial Summary

Natural history multicenter, prospective, observational registry with 10-year follow-up

Clinical Trial Description

Spontaneous coronary artery dissection (SCAD) is an under-diagnosed and poorly understood condition that frequently affects young women without conventional cardiovascular (CV) risk factors and can result in myocardial infarction (MI), cardiac arrest, and death. This condition has not been adequately studied, and there are no randomized controlled trials to guide treatment. Furthermore, SCAD has been frequently misdiagnosed due to the current "gold-standard" coronary angiography limitations. As such, there are uncertainties with the diagnosis and management of SCAD patients. Therefore, the investigators propose a large prospective multicenter Canadian SCAD Study to ascertain the natural history of predisposing arteriopathies and treatment strategy on short and long-term CV outcomes to design future randomized controlled trials. This is a multicenter, prospective, international, observational natural history study with a planned total enrolment of 3,000 patients with SCAD. The investigators plan to recruit patients from major cardiac catheterization centers across Canada and several centers in the United States and internationally. The research team successfully enrolled 750 patients prospectively in the "Canadian SCAD Cohort Study" from 22 sites in North America. This current study will be an extension of that study, now named the "Canadian SCAD Study." It will continue enrolment for a total of 3,000 patients internationally (from >35 sites). Detailed baseline demographics, targeted history for precipitating stressors and predisposing conditions, and investigations for predisposing conditions will be performed during the study. Patients will be prospectively followed long-term for up to 10 years for CV events. The study is approved, allowing potential participants to be enrolled using an electronic consent form irrespective of their geographic location and directly communicating with the study team at UBC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04906356
Study type	Observational
Source	Cardiology Research UBC
Contact	Andrew Starovoytov, MD
Phone	6048755079
Email	a.starovoytov@ubc.ca
Status	Recruiting
Phase
Start date	December 1, 2018
Completion date	December 1, 2033

View Details

See also
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Completed	`NCT03390998` - Angiographic and Psychosocial Evaluation of Peripartum vs. Non: SCAD
Completed	`NCT02799186` - The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection.	N/A
Enrolling by invitation	`NCT01427179` - Genetic Investigations in Spontaneous Coronary Artery Dissection (SCAD)
Recruiting	`NCT04496687` - International Spontaneous Coronary Artery Dissection (SCAD) "iSCAD" Registry
Active, not recruiting	`NCT02188069` - Canadian SCAD Study
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Recruiting	`NCT04457544` - Spontaneous Coronary Artery Dissection National Swiss Registry
Not yet recruiting	`NCT04850417` - Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection	Phase 4
Withdrawn	`NCT03335020` - Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.