Clinical trial NCT06955663: Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection
Official title: Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection- a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spontaneous Coronary Artery Dissection
Keywords: Sponaneous coronary artery dissection
Exercise
Randomised controlled trial
Rehabilitaiton
Fesability
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: Edinburgh Napier University
First posted: 2025-05-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: From initial patient identification until the patient consents to be part of the study. This may take up to 14 days (from initial approach until full informed consent is obtained).
measure: Adherence
timeFrame: At week 8 (56 days) of the intervention.
measure: Acceptability
timeFrame: At 24 (168 days) of the intervention (this is follow up time point three (T3)).
measure: Signal of efficacy: Changes in exercise duration
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Signal of efficacy: Changes in exercise intensity
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Secondary outcomes:
measure: Self-efficacy: Self-efficacy questionnaire
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Chest pain: Seattle Angina Questionnaire-7
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Wellbeing: Warwick Edinburgh Mental Wellbeing Scale
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Anxiety: Generalised Anxiety Disorder
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Anxiety: Cardiac Anxiety Questionnaire
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Demographic and health data: Age
timeFrame: At baseline/Day 1 (T1).
measure: Demographic and health data: Sex
timeFrame: At baseline/Day 1 (T1).
measure: Demographic and health data: Ethnicity
timeFrame: At baseline/Day 1 (T1).
measure: Demographic and health data: Number of Spontaneous Coronary Dissection (SCAD) events
timeFrame: At baseline/Day 1 (T1).
measure: Demographic and health data: Smoking status
timeFrame: At baseline/Day 1 (T1).
measure: Physical activity: International Physical Activity Questionnaire - short version
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Physical function: 6 Minute Walk Test
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
measure: Physical function: Sit to stand test
timeFrame: At week 1 (T1) of the intervention and at the end of the intervention at week 12 (T2) and at follow up of week 24 (T3).
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: David Adlam, BA BM BCh DPhil FRCP FESC
role: PRINCIPAL_INVESTIGATOR
References:
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