NCT05551429

Brief Summary

Acute coronary syndrome (ACS) is one of the most important causes of mortality and morbidity all over the world. Cardiac rehabilitation (CR) is a crucial part of secondary prevention and optimal care of patients with ACS. However, the participation rate in CR after ACS is far from expected. In our study, we will aim to examine the rate of participation in cardiac rehabilitation and the factors affecting it in patients followed up for acute coronary syndrome in the coronary intensive care unit of our hospital. Our main hypothesis is that the lower rate of participation in cardiac rehabilitation in patients with acute coronary syndrome is associated with one or more of that older age, female gender, multimorbidity, poor functional capacity, lower health literacy level or quality of life levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

September 15, 2022

Last Update Submit

January 19, 2024

Conditions

Keywords

Acute Coronary SyndromeCardiac RehabilitationMyocardial InfarctionParticipationHealth LiteracyRehabilitation Barriers

Outcome Measures

Primary Outcomes (1)

  • Rate of participation in the CR

    Number of patients admitted to the first CR session four weeks after discharge from the ICU

    Four weeks after discharge from ICU

Secondary Outcomes (6)

  • Timed Up and Go Test

    At initial evaluation of the participant in ICU

  • Measurement of hand grip strength

    At initial evaluation of the participant in ICU

  • Two minute Step Test

    At initial evaluation of the participant in ICU

  • World Health Organization Quality of Life Scale-Short Form

    At initial evaluation of the participant in ICU

  • Turkish Health Literacy Scale-32

    At initial evaluation of the participant in ICU

  • +1 more secondary outcomes

Study Arms (1)

Patients with Acute Coronary Syndrome

The study sample will comprise acute coronary syndrome patients admitted to Gazi University Faculty of Medicine, Cardiology Department, Coronary Intensive Care Unit because of one or more of the diagnoses of acute ST-elevation myocardial infarction (MI), acute non-ST elevation MI and unstable angina pectoris. Patients who are hemodynamically stable and have no signs of residual ischemia after acute care will be informed by the cardiologist about the study. After the inclusion process, patients will be evaluated in terms of clinical characteristics, muscle strength, quality of life, and health literacy. They will be given detailed information about CR and an appointment will be made four weeks later for starting the exercise program. In the follow-up, the Cardiac Rehabilitation Barriers Scale-Turkish Version will be applied to those who do not participate in the initial exercise program.

Behavioral: Invitation to the CR

Interventions

1. Oral and written information emphasise the benefits of cardiac rehabilitation in terms of treatment of heart diseases, increasing functional capacity, reducing morbidity and mortality, and enhancing secondary prevention. 2. Introducing the scope and method of administration of CR to patients. 3. Setting up the appointment for the initial CR session four weeks later.

Patients with Acute Coronary Syndrome

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-75 years admitted to the coronary intensive care unit with the diagnosis of acute coronary syndrome

You may qualify if:

  • Being hospitalized in the coronary intensive care unit with the diagnosis of acute coronary syndrome
  • Being able to walk and get up from a chair without the support of a person
  • Agree to take part in the study

You may not qualify if:

  • Presence of any conditions that prevent exercise training (severe orthopaedic, neurological or rheumatological disease, acute infection, acute pericarditis, endocrine and metabolic disorders, etc.)
  • Presence of neuropsychiatric diseases or conditions that may prevent cooperation
  • Persisting unstable angina
  • Having severe stenosis or insufficiency of heart valve
  • Congenital structural heart diseases
  • Presence of decompensated heart failure
  • Uncontrolled arrhythmias that may cause hemodynamic instability during exercise
  • Exercise contraindication decision of the cardiologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (6)

  • Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.

    PMID: 27353128BACKGROUND
  • Pio CSA, Chaves G, Davies P, Taylor R, Grace S. Interventions to Promote Patient Utilization of Cardiac Rehabilitation: Cochrane Systematic Review and Meta-Analysis. J Clin Med. 2019 Feb 5;8(2):189. doi: 10.3390/jcm8020189.

    PMID: 30764517BACKGROUND
  • Grace SL, Krepostman S, Brooks D, Jaglal S, Abramson BL, Scholey P, Suskin N, Arthur H, Stewart DE. Referral to and discharge from cardiac rehabilitation: key informant views on continuity of care. J Eval Clin Pract. 2006 Apr;12(2):155-63. doi: 10.1111/j.1365-2753.2006.00528.x.

    PMID: 16579824BACKGROUND
  • Ades PA, Keteyian SJ, Wright JS, Hamm LF, Lui K, Newlin K, Shepard DS, Thomas RJ. Increasing Cardiac Rehabilitation Participation From 20% to 70%: A Road Map From the Million Hearts Cardiac Rehabilitation Collaborative. Mayo Clin Proc. 2017 Feb;92(2):234-242. doi: 10.1016/j.mayocp.2016.10.014. Epub 2016 Nov 15.

    PMID: 27855953BACKGROUND
  • Coşkun, Özge Keniş, et al. Validity and reliability of the Turkish version of cardiac rehabilitation barriers scale. Gülhane Tip Dergisi 61.2 (2019): 59.

    BACKGROUND
  • Okyay, P., et al. A new Health Literacy Scale: Turkish Health Literacy Scale and its psychometric properties: Pinar Okyay. The European Journal of Public Health 25.suppl_3 (2015): ckv175-220.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeCardiovascular DiseasesMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Nesrin Demirsoy, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Levent Karataş, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 22, 2022

Study Start

September 22, 2022

Primary Completion

December 11, 2023

Study Completion

January 12, 2024

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations