Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection

NCT ID: NCT06955663

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-12-31

Brief Summary

The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks). Heart attacks caused by SCAD are different to the traditional heart attacks. In SCAD a tear happens within the blood vessels causing partial or full blockage. The population affected by SCAD is hugely different to the population affected by other 'traditional' heart attacks; as SCAD mainly happens in otherwise healthy women. From historical cases, SCAD has been associated with strenuous exercise, however, medical research did not find a link. The recovery after SCAD is also very different from other 'traditional' heart attacks. Cardiac rehab programmes are designed for an older population therefore they may not be suitable for a younger predominantly female population. This study will examine if a remote-exercise programme is achievable in people after a SCAD event.

Detailed Description

Spontaneous coronary artery dissection (SCAD) is a rare condition that leads to myocardial infraction (MI). Young women make up 87-95% of SCAD events, which is also the leading cause of MIs occurring after pregnancy. Following any MI event, cardiovascular rehabilitation (CR) is recommended, which includes supervised exercise sessions, and interventions to reduce risk factors, improve psychosocial wellbeing, and increase medication adherence. Evidence from randomised controlled trials (RCTs) show that CR reduces cardiac events and decreases mortality but this evidence is largely generated in a population with atherosclerotic disease. Trials of CR include mostly male participants, typically aged in their mid-sixties therefore CR guidelines may not be appropriate for the SCAD population who significantly differ in pathophysiology, age and gender compared with the population for which CR has been developed and tested.

Previous observational data suggested an association with strenuous exercise and SCAD, however, no casual link has been established. Clinical advice on exercise following SCAD is conflicting due to the lack of RCTs and therefore evidence. Consequently, many SCAD patients experience psychological distress, fear, and anxiety about exercise, avoiding all exercise which may lead to predictable long-term health consequences. Well-tested recovery programmes in SCAD are required to offer informed and tested exercise-based support to reduce the fear and hesitancy that may lead to exercise avoidance. This is particularly needed for women, who constitute the majority of SCAD diagnoses but are less likely to be referred to, attend, or adhere to CR. Small studies have explored the feasibility of SCAD survivors' participation in CR , however, programmes in these studies used conservative guidance preventing participants to reach pre-morbid exercise levels. This is problematic as (a) if participants are asked to exercise at levels well below their functional capacity, a rehabilitation effect is unlikely (b) such advice potentially reinforces that only lower levels of exercise are safe. This highlights the challenges SCAD survivors have in knowing what is safe and effective in terms of exercise. Therefore, this project aims to improve what we know about exercise and physical activity after SCAD.

The investigators will aim to test if women who have survived a SCAD will take part in a two-arm feasibility randomised controlled study of a 12-week remote exercise programme, what levels of exercise duration and intensity they achieve, and what they think about it. The two-arm design (usual care + blinded wearable activity monitor [control] and exercise intervention, + cardiopulmonary exercise test(CPET), + wearable activity monitor [intervention]) has been chosen to allow for the use of CPET at baseline to ensure safe exercise prescription.

Conditions

Spontaneous Coronary Artery Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise Intervention

12 week exercise intervention, + cardiopulmonary exercise test (CPET) + wearable activity monitor for the intervention period

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor

Usual care

Usual car + blinded activity monitor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• Aged ≥18 years.
• Diagnosed with angiographically confirmed SCAD and referred to the Leicester SCAD clinic.
• Ejection fraction >45%.
• Blood pressure <180/100. Resting heart rate <100bpm

Exclusion Criteria

• No SCAD diagnosis.
• Unable to travel to Leicester Hospital for their SCAD clinic appointment.
• Unable to give informed consent.
• No smart phone or internet access
• Unable to understand verbal explanations in English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

Edinburgh Napier University

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Adlam, BA BM BCh DPhil FRCP FESC

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

University Hospitals of Leicester

Leicester, Leicestershire, United Kingdom

Countries

United Kingdom

Central Contacts

Noemi Vadaszy, BSc, MSc, PhD

Role: CONTACT

nv96@leicester.ac.uk

+ 44 116 258 3828

Facility Contacts

Noemi Vadaszy, BSc MSc PhD

Role: primary

nv96@leicester.ac.uk

+ 44 116 258 2838

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Other Identifiers

SCOT23-100002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1018

Identifier Type: -

Identifier Source: org_study_id