Long-term Benefits of Cardiac Rehabilitation Programme

Cardiovascular Risk Factor Clinical Trial

Official title:

Long-term Benefits of Cardiac Rehabilitation Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627311
• Other study ID #: IAssistenciaSanitaria
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2020
• Source: Institut d'Assistència Sanitària
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Risk Factor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Assistència Sanitària

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Risk Factors control	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	Incidence of Major Adverse Cardiovascular Events (MACE)	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