Long-term Benefits of Cardiac Rehabilitation Programme | NCT04627311

Studies
Long-term Benefits of Cardiac Rehabilitation Programme

NCT04627311

Sponsor

Institut d'Assistència Sanitària

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

213Actual

Phase

Not provided

Conditions

Cardiovascular Risk Factor
Cardiac Rehabilitation

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Nov 8, 2020

First Submission Date that Met QC Criteria

Nov 8, 2020

First Posted Date

Nov 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

213Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample