Condition category
Circulatory System
Date applied
05/06/2019
Date assigned
10/06/2019
Last edited
10/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2022

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

Trial website

https://scad.lcbru.le.ac.uk/

Contact information

Type

Scientific

Primary contact

Dr David Adlam

ORCID ID

http://orcid.org/0000-0002-0080-9884

Contact details

Department of Cardiovascular Sciences
University of Leicester
Glenfield Hospital
Groby Road
Leicester
LE3 9DU
United Kingdom
+44 1162044751
da134@le.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

14/EM/0056

Study information

Scientific title

Epidemiology, management, outcomes and pathophysiology of SCAD

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

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

Study design

Observiational study with phenotyping and biomarker substudies

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

11/02/2014

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with angiographically proven SCAD (confirmed by the study team).
2. Healthy volunteers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,000

Participant exclusion criteria

Iatrogenic, atherosclerotic or traumatic dissections

Recruitment start date

19/08/2013

Recruitment end date

31/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiovascular Sciences
Glenfield Hospital Groby Road
Leicester
LE3 9DU
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research Governance Office
Academic Department
Ground Floor
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 258 4077
UOLSPONSOR@leicester.ac.uk

Sponsor type

University/education

Website

https://www2.le.ac.uk/colleges/medbiopsych/research/researchgovernance

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United Kingdom

Funder name

NIHR rare diseases translational collaboration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beat SCAD

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR Leicester biomedical research centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study findings will be published in peer reviewed journals.

IPD sharing statement:
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/)

Intention to publish date

01/01/2018

Participant level data

Stored in repository

Basic results (scientific)

The first common genetic variant of SCAD (PHACTR1) has been published in collaboration with partners in the Mayo Clinic, France, New York and Australia.
A study on intracoronary imaging in SCAD has also been published and shows findings which suggest the primary pathophysiological mechanism for SCAD may relate to a spontaneous intramural bleed.

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30878439 (added 05/06/2019)
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30621952 (added 05/06/2019)

Publication citations

Additional files

Editorial Notes

10/06/2019: Trial’s existence confirmed by NHS HRA NRES Committee East Midlands - Nottingham 1.