Spontaneous Coronary Artery DissectionSwissSCADNCT04457544
Spontaneous Coronary Artery Dissection National Swiss Registry
An observational study of Spontaneous Coronary Artery Dissection, run by Dr. Sophie Degrauwe at 1 site in Switzerland.
Trial summary
Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Coronary Artery Dissection
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Aug 2020to 30 Jun 2030
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: This observational study will recruit consecutive male and female patients presenting with newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years. For the purposes of study inclusion, the definition of SCAD will be based on a central review of the coronary angiographic images confirmed by 2 independent assessors
Who may be able to join
- Subject is ≥18 years of age.
- Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
- Subject must be willing to sign a Patient Informed Consent (PIC).
Who cannot join
- Patient unwilling or unable to provide informed consent.
- Patients with atherosclerotic or iatrogenic coronary dissection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, 1205
Sophie Degrauwe, MD, sophie.degrauwe@hcuge.ch
Véronique Menoni, veronique.menoni@hcuge.ch
About this study
Official title: Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)
Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.
Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.
In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.
- Conditions
- Spontaneous Coronary Artery Dissection
- Medical subject headings
- Coronary Artery Dissection, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective patients | The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm. | |
| Prospective patients | Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of safety events at 30 days
Incidence of Major cardiovascular outcomes (MACE) at 30 days
Measured: 30 days
Secondary outcomes (2)
Incidence of safety events at 1 year
Incidence of Major cardiovascular outcomes (MACE) at 1 year
Measured: 1 year
Incidence of safety events at 5 years
Incidence of Major cardiovascular outcomes (MACE) at 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Aug 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Coronary Artery DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dr. Sophie Degrauwe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sophie Degrauwe, University Hospital, Geneva
- Investigators
- Sophie Degrauwe, Dr, Principal investigator, Hopitaux universitaires de Geneve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457544
- Sponsor's protocol ID
- 2019-01886
- Other IDs
- 2019
- Acronym
- SwissSCAD
- Status last verified
- Nov 2022
- First submitted
- 16 Jun 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Coronary Artery Dissection (SCAD) National Swiss Registry (SwissSCAD)
- ClinicalTrials.gov ID
- NCT04457544
- Acronym / sponsor ID
- SwissSCAD / 2019-01886
- Conditions
- Spontaneous Coronary Artery Dissection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dr. Sophie DegrauweUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spontaneous coronary artery dissection (SCAD), is an underdiagnosed pathology, affecting predominantly young women without traditional cardiovascular risk factors and is associated with major adverse outcomes including myocardial infarction, cardiac arrest, or death.
Timely diagnosis of SCAD as well as clinical follow-up are of the essence in this pathology associated with major cardiac adverse outcomes. Despite recent improvements in diagnosis and recognition of the importance of SCAD, it remains poorly studied and understood.
In this context, we designed the SwissSCAD registry, a large, observational, prospective, cohort study, to describe the natural history of SCAD, its outcomes and its treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective patients | – | –The investigators will review the hospital records at the investigational site for SCAD events having occurred over the last 5 years. All SCAD patients aged ≥18 years, not presenting atherosclerotic or iatrogenic coronary dissection will be informed about the SwissSCAD study by phone and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the retrospective arm. |
| Prospective patients | – | –Patients presenting at the hospital with newly diagnosed SCAD will be informed of the SwissSCAD study and will be given at least one week to decide if they wish to participate. We plan to include 500 patients in the prospective arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This observational study will recruit consecutive male and female patients presenting with newly diagnosed SCAD or having been diagnosed with SCAD within the last 5 years. For the purposes of study inclusion, the definition of SCAD will be based on a central review of the coronary angiographic images confirmed by 2 independent assessors
Key inclusion criteria (3 listed)
- Subject is ≥18 years of age.
- Patient presenting newly diagnosed SCAD or diagnosed with SCAD within the last 5 years.
- Subject must be willing to sign a Patient Informed Consent (PIC).
Key exclusion criteria (2 listed)
- Patient unwilling or unable to provide informed consent.
- Patients with atherosclerotic or iatrogenic coronary dissection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of safety events at 30 days
Time frame: 30 days
Incidence of Major cardiovascular outcomes (MACE) at 30 days
2 secondary outcomes
Incidence of safety events at 1 year
Time frame: 1 year
Incidence of safety events at 5 years
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Degrauwe, Dr principal investigator
Hopitaux universitaires de Geneve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Coronary Artery Dissection, run by Dr. Sophie Degrauwe at 1 site in Switzerland.
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 3 inclusion and 2 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 16 Nov 2022. 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 Switzerland. 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 Sophie Degrauwe, Dr (+41795530294, sophie.degrauwe@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of safety events at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2022.