Spontaneous coronary artery dissection (SCAD) study
| ISRCTN | ISRCTN42661582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42661582 |
| IRAS number | 141202 |
| Secondary identifying numbers | 14/EM/0056 |
- Submission date
- 05/06/2019
- Registration date
- 10/06/2019
- Last edited
- 25/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Spontaneous coronary artery dissection (SCAD) is a rare cause of acute myocardial infarction with an increased incidence in young women, particularly in the period around giving birth. To date research into this condition in the UK and internationally has been very limited. We propose to undertake (i) detailed vascular phenotypingof an anticipated minimum of 280 patients with a history of SCAD (and matched controls) to determine if the coronary abnormality in SCAD is part of a wider arteriopathy and (ii) investigate whether predilection to SCAD is genetically-based.
Who can participate?
Patients with angiographically proven SCAD (confirmed by the study team) and healthy volunteers.
What does the study involve?
The study involves two elements. Firstly, a registry of patients who have had spontaneous coronary artery dissection and agree to provide access to their medical records, complete questionnaires and provided a blood sample for the research study. Secondly, some patients are invited for a clinical visit day when they undergo lots of different tests to try to understand in what ways their arteries are different from healthy people and to collect samples (blood and sometimes a skin biopsy) to advance laboratory research to understand the causes of SCAD.
What are the possible benefits and risks of participating?
The benefits are altruistic in terms of advancing our understanding of SCAD for the benefit of future patients with this condition. The risks relate only to the blood sampling and skin biopsy (in some patients) which can cause some local discomfort or bruising.
Where is the study run from?
Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, UK
When is the study starting and how long is it expected to run for?
August 2013 to March 2024
Who is funding the study?
1. British Heart Foundation
2. NIHR rare diseases translational collaboration
3. Beat SCAD
4. NIHR Leicester biomedical research centre
Who is the main contact?
Dr David Adlam,
da134@le.ac.uk
Contact information
Scientific
Department of Cardiovascular Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9DU
United Kingdom
 ORCID ID |
0000-0002-0080-9884 |
|---|---|
| Phone | +44 1162044751 |
| da134@le.ac.uk |
Study information
| Study design | Observiational study with phenotyping and biomarker substudies |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Epidemiology, management, outcomes and pathophysiology of SCAD |
| Study acronym | SCAD |
| Study hypothesis | 1. SCAD is associated with remote arteriopathies demonstrable by non-invasive imaging (MRA) and measureable abnormalities of vascular elasticity, compliance and reactivity compared to age and sex-matched controls 2. SCAD has an identifiable genetic basis |
| Ethics approval(s) | Approved 13/03/2014, NRES Committee East Midlands - Nottingham 1 (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0115 8839695; NRESCommittee.EastMidlands-Nottingham1@nhs.net), ref: 14/EM/0056 |
| Condition | Spontaneous coronary artery dissection |
| Intervention | The study has two elements. The first is an observational registry. Consenting patients allow access to their medical information and clinical imaging at the time and following their Spontaneous Coronary Artery Dissection event and complete a detailed set of online questionnaires. They provide a blood sample for biobanking and DNA. Follow-up questionnaires are also provided annually. The second element is a deep phenotyping study. Selected patients from the registry are invited to attend for a range of phenotyping investigations which may include: magnetic resonance imaging, magnetic resonance angiography, computed tomography coronary angiography, computed tomography angiography, vascular ultrasound, exercise testing, ambulatory ECG monitoring, retinal photography. A clinical assessment blood sample and skin biopsy sample may be taken. |
| Intervention type | Other |
| Primary outcome measure | 1. Presenting clinical data from index admission with Spontaneous Coronary Artery Dissection, review of patient notes and imaging, at baseline 2. Demographic, medical, obstetric, contraceptive and family history, review of patient notes, online (bespoke) questionnaires, patient interview, at time of registration 3. Coronary angiographic findings, patient imaging data, at baseline 4. MACCE, SCAD recurrence, pregnancy at follow-up, questionnaires clarified by patient interview if required, annually |
| Secondary outcome measures | 1. CMR assessment of myocardial function and infarct size, either from scans conducted on clinical grounds or research scans arranged as part of the phenotyping study 2. MRA/CTA assessment of remote arteriopathies either from scans conducted on clinical grounds or research scans arranged as part of the phenotyping study 3. USS assessment of arteries including FMD, IMT, luminal dimensions arranged as part of the phenotyping study 4. Cardiopulmonary exercise testing arranged as part of the phenotyping study 5. Ambulatory ECG monitoring conducted either on clinical grounds or arranged as part of the phenotyping study 6. Blood sampling for biomarkers and genetic studies 7. Skin biopsies for fibroblast culture for laboratory assays |
| Overall study start date | 11/02/2014 |
| Overall study end date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,000 |
| Participant inclusion criteria | 1. Patients with angiographically proven SCAD (confirmed by the study team). 2. Healthy volunteers |
| Participant exclusion criteria | Iatrogenic, atherosclerotic or traumatic dissections |
| Recruitment start date | 19/08/2013 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Groby Road
Leicester
LE3 9DU
United Kingdom
Sponsor information
University/education
Research Governance Office
Academic Department, Ground Floor
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 116 258 4077 |
|---|---|
| UOLSPONSOR@leicester.ac.uk | |
| Website | https://www2.le.ac.uk/colleges/medbiopsych/research/researchgovernance |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Study findings will be published in peer reviewed journals. |
| IPD sharing plan | Patient level data are not expected to be made publically available because of issues of patients confidentiality in what is an uncommon disease. Summary data will be presented in publically available peer reviewed manuscripts and posted on the study website (https://scad.lcbru.le.ac.uk/) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2019 | 05/06/2019 | Yes | No |
| Results article | results | 08/01/2019 | 05/06/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/03/2024.
2. The overall trial end date has been changed from 31/03/2022 to 31/03/2024 and the plain English summary has been updated to reflect this change.
3. The IRAS number has been added.
10/06/2019: Trial’s existence confirmed by NHS HRA NRES Committee East Midlands - Nottingham 1.
