Coronary Artery Disease (CAD);Phase 3SAINTEX-CADNCT01226225
A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.
A Phase 3 study testing Aerobic interval training and Moderate endurance training in people with Coronary Artery Disease (CAD); and Myocardial Infarction (MI), run by University Hospital, Antwerp at 2 sites in Belgium.
Trial summary
Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease (CAD);, Myocardial Infarction (MI), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Aerobic interval training and Moderate endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2010to Sep 2013
- Phase
- Phase 3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) > 40%
- the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of > 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
- patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
- in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG
Who cannot join
- significant intercurrent illness last 6 weeks
- known severe ventricular arrhythmia with functional or prognostic significance
- significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- recent CABG (< 30 days)
- other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
- co-morbidity that may significantly influence one-year prognosis
Show all 13Show fewer
- functional or mental disability that may limit exercise
- a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion
- acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
- glomerular filtration rate (GFR) <25ml/min/1.73m2
- hemoglobin < 10g/dl
- severe chronic obstructive pulmonary disease
- participation in another clinical trial
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Dienst Cardiale Revalidatie, Cardiologie, Universitair Ziekenhuis Antwerpen
Edegem, 2650
Viviane M Conraads, MD,PhD, 38214672 ext. 0032, Viviane.Conraad@uza.be
- Not yet recruiting
Universitair Ziekenhuis Leuven, Dienst Hart- en Vaatziekten, Cardiale Revalidatie Herestraat 49
Leuven, 3000
Luc VanHees, MSc, PhD, 16-329158 ext. 0032, Luc.Vanhees@faber.kuleuven.be
About this study
Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. The ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). The main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. During interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity.
In addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.
- Conditions
- Coronary Artery Disease (CAD);, Myocardial Infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
- Being tested
- Aerobic interval training, Moderate endurance training
- Keywords
- Patients with recent coronary event
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingBehavioural
Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.
Moderate endurance trainingBehavioural
Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic interval training | Experimental | Not described Receives: Behavioral: Aerobic interval training |
| Moderate endurance training | Active comparator | Not described Receives: Behavioral: Moderate endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks
Measured: 6 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks
Measured: 12 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD);Studies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226225
- Sponsor's protocol ID
- IWT-090870
- Acronym
- SAINTEX-CAD
- Status last verified
- Aug 2010
- First submitted
- 19 Aug 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Trial on the Effectiveness of Physical Rehabilitation of Patients With Coronary Artery Disease: Aerobic Interval Training Versus Moderate Continuous Training.
- ClinicalTrials.gov ID
- NCT01226225
- Acronym / sponsor ID
- SAINTEX-CAD / IWT-090870
- Conditions
- Coronary Artery Disease (CAD);, Myocardial Infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
- Keywords
- Patients with recent coronary event
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Study start
- Nov 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 22 Oct 2010 (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.
Cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. Besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. The ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). The main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. During interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. Such intervals are repeated. Preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity.
In addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training | Experimental | Behavioral: Aerobic interval training |
| Moderate endurance training | Active comparator | Behavioral: Moderate endurance training |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with CAD (post-PCI, post-MI, post-CABG) and a left ventricular ejection fraction (LVEF) > 40%
- the presence of CAD is defined as prior angiographically documented stenotic lesion(s) of > 75%, or documented myocardial infarction (biochemical, ECG, echocardiographic documentation).
- patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
- in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of PCI, MI or CABG
Key exclusion criteria (13 listed)
- significant intercurrent illness last 6 weeks
- known severe ventricular arrhythmia with functional or prognostic significance
- significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- recent CABG (< 30 days)
- other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
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 |
|---|---|---|
| Aerobic interval trainingPatients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months. | Behavioural | Aerobic interval training |
| Moderate endurance trainingPatients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months. | Behavioural | Moderate endurance training |
Primary outcome
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Time frame: 6 weeks
Comparison of evolution of maximal aerobic capacity from baseline to 6 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Time frame: 12 weeks
Comparison of evolution of maximal aerobic capacity from baseline to 12 weeks
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Time frame: 12 months
Comparison of evolution of maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aerobic interval training and Moderate endurance training in people with Coronary Artery Disease (CAD); and Myocardial Infarction (MI), run by University Hospital, Antwerp at 2 sites 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viviane M Conraads, MD, PhD (38214672 ext. 0032, Viviane.Conraads@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal aerobic capacity, measured during symptom-limited cardio-pulmonary exercise testing (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 10 Nov 2010.