Long-term Benefits of Cardiac Rehabilitation Programme

November 8, 2020 updated by: Institut d'Assistència Sanitària
A retrospective observational study was conducted on a cohort of 213 patients referred to the Cardiac Rehabilitation programme of Santa "Caterina" Hospital ("Girona", Spain) following acute coronary syndrome (ACS). We evaluated the long-term control of Cardiovascular Risk Factors and the occurrence of major adverse cardiac events (MACE) in a 3-year period of follow-up.

Study Overview

Status

Completed

Conditions

Detailed Description

A retrospective observational study was conducted on a cohort of 213 patients referred to the Cardiac Rehabilitation programme of "Santa Caterina" Hospital ("Girona", Spain) following acute coronary syndrome (ACS). We evaluated the long-term control of Cardiovascular Risk Factors and the occurrence of major adverse cardiac events (MACE) in a 3-year period of follow-up.

we found that short-term CVRF control was significantly improved after discharge from the CR unit for all CVRF analysed (LDLc, Systolic blood pressure, tobacco consumption, HbA1C and BMI (body mass index)). Long-term control of low-density lipoprotein cholesterol (LDL-c) and tobacco consumption was maintained from post-CR to year three, although both showed a trend towards deterioration. There was a significant increase in systolic blood pressure and glycosylated haemoglobin (HbA1C) and body mass index (BMI) from post-CR to year three.

Study Type

Observational

Enrollment (Actual)

213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive individuals referred to the hospital-based Cardiac Rehabilitation programme through the Cardiology unit at Santa Caterina Hospital of Girona, after suffering an ACS, with a 3-year period follow-up. A target population of 227 patients were referred to the CR unit during this period. According to inclusion and exclusion criteria, 213 patients were recruited in the retrospective analysis of Girona's health region.

Description

Inclusion Criteria:

  • Patients enrolled in the hospital-based Cardiac Rehabilitation programme of Santa Caterina Hospital of Girona from January 2008, with a 3-year period follow-up.
  • Patients diagnosed with ACS - including STEMI, NSTEMI and unstable angina (UA) admitted in the cardiology unit of Santa Caterina Hospital of Girona and Hospital Universitari Dr. Josep Trueta of Girona.
  • Patients able to read the information paper and to provide written informed consent of the Cardiac Rehabilitation programme of the Santa Caterina Hospital.

Exclusion Criteria:

  • Patients enrolled in the hospital-based Cardiac Rehabilitation programme of Santa Caterina Hospital of Girona with a different diagnosis of heart disease: cardiovascular surgery, congestive heart failure, heart valve disease, etc.
  • Data unavailable for a 3-year follow-up study ± 6 months.
  • Patients with severe comorbidities or limitation for physical activity, and thus, inability to undergo Cardiac Rehabilitation programmes.
  • Stress test with induced significative ischemia with low charge of exercise, arrhythmia induced with the exercise or hypotension response to this.
  • Ventricular arrhythmias and other malignant arrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Risk Factors control
Time Frame: 3 years
To determine whether the control of the CVRF (tobacco consumption, hypertension, hyperlipidaemia, diabetes mellitus type 2 and overweight) is maintained at long term (after 3 years of discharge of the CR unit), among all patients referred to the hospital-based CR programme of Santa "Caterina" Hospital from "Girona" area, after suffering an ACS.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: 3 years

To determine the incidence of MACE (Major Adverse Cardiovascular Events:

ACS, need for revascularization by percutaneous intervention or coronary artery bypass grafting (CABG), stroke, cardiovascular death and/or sudden death) among all patients post-ACS referred to the hospital-based CR programme of Santa "Caterina" Hospital, after 3 years of follow-up.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Assistència Sanitària

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 8, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • IAssistenciaSanitaria

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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