Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection

NCT06955663 | Not Yet Recruiting

• 2 other identifiers: 1018SCOT23-100002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Coronary Artery Dissection

Keywords

Sponaneous coronary artery dissection; Exercise; Randomised controlled trial; Rehabilitaiton; Fesability

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Rate of successful recruitment

  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).

• Adherence

  Rate of successful adherence

  At week 8 (56 days) of the intervention.

• Acceptability

  Acceptability of the intervention assessed via qualitative interviews which will be then transcribed verbatim. Acceptability will be assessed via thematic analysis of semi-structured interviews. Once patients completed T3 (+/- 7 days), they will be invited to take part in semi-structured interviews.

  At 24 (168 days) of the intervention (this is follow up time point three (T3)).

• Signal of efficacy: Changes in exercise duration

  Changes in exercise duration expressed in time (hours: minutes) measured by the activity monitor(s) over the study period.

  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).

• Signal of efficacy: Changes in exercise intensity

  Changes in exercise intensity expressed in period(s) of time spent (hours: minutes) performing light, moderate, and/or heavy intensity exercise.

  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 (13)

• Self-efficacy: Self-efficacy questionnaire

  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).

• Chest pain: Seattle Angina Questionnaire-7

  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).

• Wellbeing: Warwick Edinburgh Mental Wellbeing Scale

  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).

• Anxiety: Generalised Anxiety Disorder

  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).

• Anxiety: Cardiac Anxiety Questionnaire

  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).

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

Behavioral: Exercise training

Usual care

NO INTERVENTION

Usual car + blinded activity monitor

Interventions

Exercise training BEHAVIORAL

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

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• Edinburgh Napier University: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (13)

• Hanson CL, Kelly P, Neubeck L, Bell J, Gibb H, Jin K. The Contribution of Leisure Center Usage to Physical Activity in the United Kingdom: Evidence From a Large Population-Based Cohort. J Phys Act Health. 2021 Mar 3;18(4):382-390. doi: 10.1123/jpah.2020-0422. Print 2021 Apr 1.

  PMID: 33657530 BACKGROUND

• Neubeck L, McHale S, Ross M, MacGillivray S, Galbraith M, Hanson C. Spontaneous coronary artery dissection: a systematic review of physical and psychosocial recovery following discharge from hospital. Eur J Cardiovasc Nurs. 2022 Oct 14;21(7):665-676. doi: 10.1093/eurjcn/zvac009.

  PMID: 35290455 BACKGROUND

• Silber TC, Tweet MS, Bowman MJ, Hayes SN, Squires RW. Cardiac rehabilitation after spontaneous coronary artery dissection. J Cardiopulm Rehabil Prev. 2015 Sep-Oct;35(5):328-33. doi: 10.1097/HCR.0000000000000111.

  PMID: 25730096 BACKGROUND

• Imran H, Gaw A, Stabile L, Shah N, Choudhary G, Wu WC. Safety and Outcomes of Cardiac Rehabilitation for Patients with Spontaneous Coronary Artery Dissection. J Rehabil Med Clin Commun. 2018 May 23;1:1000001. doi: 10.2340/20030711-1000001. eCollection 2018.

  PMID: 33884107 BACKGROUND

• Chou AY, Prakash R, Rajala J, Birnie T, Isserow S, Taylor CM, Ignaszewski A, Chan S, Starovoytov A, Saw J. The First Dedicated Cardiac Rehabilitation Program for Patients With Spontaneous Coronary Artery Dissection: Description and Initial Results. Can J Cardiol. 2016 Apr;32(4):554-60. doi: 10.1016/j.cjca.2016.01.009. Epub 2016 Jan 18.

  PMID: 26923234 BACKGROUND

• Sawan MA, Calhoun AE, Fatade YA, Wenger NK. Cardiac rehabilitation in women, challenges and opportunities. Prog Cardiovasc Dis. 2022 Jan-Feb;70:111-118. doi: 10.1016/j.pcad.2022.01.007. Epub 2022 Feb 10.

  PMID: 35150655 BACKGROUND

• Supervia M, Medina-Inojosa JR, Yeung C, Lopez-Jimenez F, Squires RW, Perez-Terzic CM, Brewer LC, Leth SE, Thomas RJ. Cardiac Rehabilitation for Women: A Systematic Review of Barriers and Solutions. Mayo Clin Proc. 2017 Mar 13:S0025-6196(17)30026-5. doi: 10.1016/j.mayocp.2017.01.002. Online ahead of print.

  PMID: 28365100 BACKGROUND

• Binnie K, Neubeck L, McHale S, Hanson CL. What do spontaneous coronary artery dissection survivors want to support their recovery? a qualitative study. Eur J Cardiovasc Nurs. 2023 Dec 14;22(8):814-823. doi: 10.1093/eurjcn/zvad013.

  PMID: 36656922 BACKGROUND

• Bouchard K, Tarannum CN, Coutinho T, So D, Tulloch H. Secondary Preventative Care for Patients After Spontaneous Coronary Artery Dissection: A Qualitative Analysis of Health Care Providers' Perspectives. Can J Cardiol. 2020 Jul;36(7):1156-1160. doi: 10.1016/j.cjca.2019.11.004. Epub 2019 Nov 11.

  PMID: 32247705 BACKGROUND

• Bouchard K, Coutinho T, Reed J, Lalande K, Tarannum CN, So D, Saw J, Mulvagh S, Tulloch H. Recovering from spontaneous coronary artery dissection: Patient-reported challenges and rehabilitative intervention needs. Health Psychol. 2021 Jul;40(7):472-479. doi: 10.1037/hea0001086.

  PMID: 34435799 BACKGROUND

• Saw J, Aymong E, Sedlak T, Buller CE, Starovoytov A, Ricci D, Robinson S, Vuurmans T, Gao M, Humphries K, Mancini GB. Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes. Circ Cardiovasc Interv. 2014 Oct;7(5):645-55. doi: 10.1161/CIRCINTERVENTIONS.114.001760. Epub 2014 Oct 7.

  PMID: 25294399 BACKGROUND

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

  PMID: 26764059 BACKGROUND

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.

  PMID: 35525570 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Adlam, BA BM BCh DPhil FRCP FESC

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemi Vadaszy, BSc, MSc, PhD

CONTACT

+ 44 116 258 3828; nv96@leicester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: External collaborators
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 2, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)