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Spontaneous Coronary Artery DissectionNCT04906356

Canadian SCAD Study

An observational study of Spontaneous Coronary Artery Dissection and SCAD, run by Cardiology Research UBC at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Natural history multicenter, prospective, observational registry with 10-year follow-up Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Genetic sub-study
How many people
3,000 participants
Where
1 siteCanada
Study dates
1 Dec 2018to 1 Dec 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted with ACS (STEMI, NSTEMI or unstable angina) and diagnosed with SCAD during direct coronary angiography. The study imaging corelab will review all films before participant enrollment.

Who may be able to join

  • Patients admitted with ACS (STEMI, NSTEMI or unstable angina)
  • Documented SCAD on a coronary angiogram (including diagnosis with OCT or IVUS)

Who cannot join

  • 1. Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrew Starovoytov, MD contact

6048755079

a.starovoytov@ubc.ca

Johandra Argote Parolis, MD contact

6048754111 ext. 63344

j.argoteparolis@ubc.ca

Canada1 site, 1 recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z1M9

    Johandra Argote Parolis, MD, 604 875 4111 ext. 63344, j.argoteparolis@ubc.ca

    Jacqueline Saw, MD

    Recruiting

Other trials in Canada

About this study

Official title: Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)

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

Read the detailed 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.

Being tested
Genetic sub-study
Keywords
Fibromuscular displasia (FMD), Myocardial Infarction, Myocardial Infarction in women, Non-atherosclerotic coronary artery disease (NACAD), Myocardial Infarction with no obstructive coronary artery disease (MINOCA), SCAD, Spontaneous Coronary Artery Dissection
Medical subject headings
Coronary Artery Dissection, Spontaneous, Fibromuscular Dysplasia, Myocardial Infarction, MINOCA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic sub-studyGenetic

    One time saliva sample collection

Study groups in NCT04906356
Study groupRoleWhat they receive
Study groupSingle group observational study
Receives: Genetic: Genetic sub-study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital CV outcomes

    Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)

    Measured: From date of hospital admission to discharge up to 8 weeks

  2. Long-term CV outcomes

    Composite (Death, MI, CVA, Revascularization, Heart failure)

    Measured: at 10 Years post index event

Secondary outcomes (2)

  1. Arterial healing post SCAD

    Angiographic healing

    Measured: at 6 weeks post discharge post index event

  2. Coronary revascularization success

    Composite (TIMI 3 flow, <50% stenosis, and no residual dissection)

    Measured: During index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2033 (estimated)
  4. Study completion1 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04906356
Sponsor's protocol ID
H18-03039
Status last verified
May 2021
First submitted
16 Apr 2021
Last updated
28 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saw J, Starovoytov A, Humphries K, Sheth T, So D, Minhas K, Brass N, Lavoie A, Bishop H, Lavi S, Pearce C, Renner S, Madan M, Welsh RC, Lutchmedial S, Vijayaraghavan R, Aymong E, Har B, Ibrahim R, Gornik HL, Ganesh S, Buller C, Matteau A, Martucci G, Ko D, Mancini GBJ. Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes. Eur Heart J. 2019 Apr 14;40(15):1188-1197. doi: 10.1093/eurheartj/ehz007.

    PubMed 30698711

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Coronary Artery Dissection and SCAD, run by Cardiology Research UBC at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrew Starovoytov, MD (6048755079, a.starovoytov@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital CV outcomes (time frame: From date of hospital admission to discharge up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04906356, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

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