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Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection

Sponsor: University of Leicester

NCT ID: NCT06955663

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Exercise training (behavioural)
How long the study runs
Study runs about 31 months (dates as stated)
About the drug or intervention
Exercise training — behavioural: 12 week exercise intervention + cardiopulmonary exercise test (CPET) + wearable activity monitor
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
120
Started
2025-05-01
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for spontaneous coronary artery dissection
  • • NA - 120 participants
  • • The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with spontaneous coronary artery dissection
  • • Female only

Where?

  • • Leicester - University Hospitals of Leicester

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Spontaneous Coronary Artery Dissection

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓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

Who cannot take part

  • ✗No SCAD diagnosis.
  • ✗Unable to travel to Leicester Hospital for their SCAD clinic appointment.
  • ✗Unable to give agreement to take part.
  • ✗No smart phone or internet access
  • ✗Unable to understand verbal explanations in English.
See the full 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.

Where Is This Study? (1 UK site)

University Hospitals of Leicester

Leicester LE3 9QP, United Kingdom

Recruiting
Site contact (verified)
David Adlam, BA BM BCh DPhil FRCP FESCPrincipal Investigator
Noemi Vadaszy, BSc MSc PhD+ 44 116 258 2838nv96@leicester.ac.uk

How to Get in Touch

Noemi Vadaszy, BSc, MSc, PhD

Sponsor contact

CONTACT

+ 44 116 258 3828 nv96@leicester.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-05