Coronary Artery DiseaseNCT03034980
Influence of Training Intensity in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Hasselt University at 1 site in Belgium.
Trial summary
Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Training intensity (workload) during ergospirometry
- How many people
- 343 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2016to 15 Sep 2017
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.
Who may be able to join
- Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must be completed.
Who cannot join
- Patients with heart failure (HFpEF and HFrEF with ejection fraction ≤40%) and valvular heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease
Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation.
The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Training intensity (workload) during ergospirometry
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training intensity (workload) during ergospirometryOther
The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) patients | Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016. Receives: Other: Training intensity (workload) during ergospirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.
Measured: up to week 12
Secondary outcomes (1)
cardiovascular risk profile
The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.
Measured: up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start20 Dec 2016
- Primary completion1 Jul 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Kaatje Goetschalckx, MD, Principal investigator, Catholic University Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034980
- Sponsor's protocol ID
- PD-VG-01
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03034980
- Acronym / sponsor ID
- PD-VG-01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation.
The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) patients | – | Other: Training intensity (workload) during ergospirometryPatients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.
Key inclusion criteria (1 listed)
- Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must be completed.
Key exclusion criteria (1 listed)
- Patients with heart failure (HFpEF and HFrEF with ejection fraction ≤40%) and valvular heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training intensity (workload) during ergospirometryThe reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2. | Other | Coronary Artery Disease (CAD) patients |
Primary outcome
exercise capacity
Time frame: up to week 12
The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.
1 secondary outcome
cardiovascular risk profile
Time frame: up to week 12
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 27 Feb 2018.
- 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.
Kaatje Goetschalckx, MD principal investigator
Catholic University Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Hasselt University at 1 site in Belgium.
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 1 inclusion and 1 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 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
exercise capacity (time frame: up to week 12). 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 27 Feb 2018.