Cardiovascular Risk FactorNCT04627311
Long-term Benefits of Cardiac Rehabilitation Programme
An observational study of Cardiovascular Risk Factor and Cardiac Rehabilitation, run by Institut d'Assistència Sanitària.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiac Rehabilitation
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 1 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Cardiac Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jan 2008
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Assistència Sanitària
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627311
- Sponsor's protocol ID
- IAssistenciaSanitaria
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Benefits of Cardiac Rehabilitation Programme
- ClinicalTrials.gov ID
- NCT04627311
- Acronym / sponsor ID
- IAssistenciaSanitaria
- Conditions
- Cardiovascular Risk Factor, Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Institut d'Assistència SanitàriaUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiac Rehabilitation, run by Institut d'Assistència Sanitària.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk Factors control (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.