AnginaSYNDEXNCT02905630
The Syndrome X-ercise Study SYNDEX
A study testing Exercise training in people with Angina, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart rate variability, endothelial function and quality of life in patients with no obstructive coronary artery disease and angina. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2014to Feb 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- outpatients and patients admitted to the hospital with a history of repeated episodes of exercise induced chest pain.
- normal or near normal coronary angiogram or negative CT coronary angiogram
- age > 18 years
- being able to participate in training groups 3 times a week.
Who cannot join
- serious valve disease
- cancer
- previous radiation or drug therapy for cancer
- musculoskeletal problems making ET impossible
- ongoing serious inflammatory disease
- intracardiac devices
Show all 12Show fewer
- presumed insufficient acoustic windows because of severe emphysema or gross overweight
- atrial fibrillation
- participation in other ongoing studies.
- contrast allergy
- contraindication to adenosine infusion
- vasospasm angina
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital
Stavanger, 4068
Alf Inge Larsen, MD, PhD, +4751513201, laai@sus.no
About this study
Official title: Effect of Aerobic High-intensity Exercise Training on Coronary Flow Reserve and Endothelial Function in Individuals With Chest Pain and Normal Coronary Angiogram
This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart rate variability, endothelial function and quality of life in patients with no obstructive coronary artery disease and angina.
Read the detailed description
Impaired coronary flow reserve (CFR) is associated with increased mortality in patients with chest pain despite normal coronary arteries (chest pain and normal coronary angiograms (CPNCA)) , . Furthermore, impaired CFR without any concomitant impairment of regional or global left ventricular function have additional prognostic significance . In patients with hypertension both microvascular dysfunction and increased left ventricular mass (LVM) are described sequels . LVM has also been associated with endothelial dysfunction and coronary artery remodelling . In addition, patients with hypertrophic obstructive cardiomyopathy (HOCM) and an impaired micro vascular cardiac circulation assessed with PET, have been documented to have a poor prognosis . Also diastolic dysfunction as measured by Em/Am ratio during stress dobutamine echocardiography is related to CFR . Patients with Diabetes Mellitus have an impaired prognosis and longstanding disease influence microvascular physiology . Several methods have been utilized to assess micro vascular function including intracoronary Doppler measurements. CRF can now be assessed with transthoracic Doppler registration .
Several patients with angina and normal coronary arteries show persistence and even worsening of angina symptoms over time. . These patients constitute a therapeutic problem with considerable residual morbidity associated with functional limitation and reduced quality of life . The primary end point in the treatment of these patients is symptom control .
Reduced physical activity is one of the major avoidance behaviours in patients with coronary heart disease . On the other hand several studies have documented the positive effect of ET in this population . Psychological morbidity with great impact on daily living is well known in both patients with cardiovascular disease and in patients with chest pain with no obvious physical disease. This includes patients with CPNCA. These patients constitute a relatively large proportion of patients taken care of by the health authority system indicating that this issue has economic consequences for the society that is not neglectable2.
Exercise training (ET) has been shown to improve endothelial function in patients with coronary artery disease (CAD) and to reduce LVM in hypertension.. ET also improves endothelial dysfunction and reverse inflammation in CAD. It is also associated with improved outcome in the general population and in patients with CAD and heart failure. It has been documented that hs-CRP correlates with symptoms and ECG markers of myocardial ischemia in CPNCA patients . Whether hs-CRP is related to the pathogenesis of angina in these patients deserves further investigation. Whether ET may influence on pathological reduced CFR is currently not known.
Interventions proposed in CPNCA patients are directed at either improving microvascular function or decreasing chest pain perception, in an attempt to counteract the accepted pathophysiological mechanisms of the syndrome. A multidisciplinary approach and a genuine, sympathetic appreciation by the health staff of the devastating effect of cardiac syndrome X on the patients' quality of life usually have a positive therapeutic impact . Unfortunately, most treatments have been evaluated in small numbers of patients and/or in uncontrolled trials, thus making it difficult to establish their real degree of effectiveness. Tynni Lee 11 investigated the effects of physical training and relaxation therapy on exercise capacity and quality of life in patients with syndrome X. It is the first trial reported to assess the effect of physiotherapy intervention in terms of quality of life in patients with coronary syndrome X. Female patients with this syndrome benefit from physical training in terms of exercise capacity and quality of life, and from relaxation therapy in terms of quality of life. However a limitation is the small sample size and therefore non-significant findings may be due to an inability to detect a difference among groups. Further studies with larger number of patients are recommended. Different modes of physiotherapy could have the potential to break the vicious circle of effort-induced chest pain, functional limitations and poor quality of life in the patients with coronary syndrome.
- Conditions
- Angina
- Being tested
- Exercise training
- Keywords
- coronary flow reserve, angina, exercise training
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
high intensity aerobic interval training
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | High intensity aerobic exercise training Receives: Other: Exercise training |
| No training | No intervention | No exercise training, only ordinary daily life activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow reserve
Changes of Cornary flow reserve following 3 months of exercise training
Measured: 3 months
Secondary outcomes (2)
Endothelial function
Arterial diameter after occlusion at baseline and at 3 months follow up
Measured: 3 months
Functional capacity
Changes in cardiopulmonary exercise testing following 3 months of exercise training
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University of Bergen, University of Stavanger
- Responsible party
- Sponsor
- Investigators
- Alf Inge Larsen, MD, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905630
- Sponsor's protocol ID
- 362Syndex
- Acronym
- SYNDEX
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Larsen AI, Saeland C, Vegsundvag J, Skadberg MS, Nilsen J, Butt N, Ushakova A, Valborgland T, Munk PS, Isaksen K. Aerobic high-intensity interval exercise training in patients with angina and no obstructive coronary artery disease: feasibility and physiological effects. Eur Heart J Open. 2023 Mar 22;3(2):oead030. doi: 10.1093/ehjopen/oead030. eCollection 2023 Mar.
PubMed 37113515
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic High-intensity Exercise Training on Coronary Flow Reserve and Endothelial Function in Individuals With Chest Pain and Normal Coronary Angiogram
- ClinicalTrials.gov ID
- NCT02905630
- Acronym / sponsor ID
- SYNDEX / 362Syndex
- Conditions
- Angina
- Keywords
- coronary flow reserve, angina, exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University of Bergen, University of Stavanger
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 19 Sep 2016 (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.
This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart rate variability, endothelial function and quality of life in patients with no obstructive coronary artery disease and angina.
Detailed description
Impaired coronary flow reserve (CFR) is associated with increased mortality in patients with chest pain despite normal coronary arteries (chest pain and normal coronary angiograms (CPNCA)) , . Furthermore, impaired CFR without any concomitant impairment of regional or global left ventricular function have additional prognostic significance . In patients with hypertension both microvascular dysfunction and increased left ventricular mass (LVM) are described sequels . LVM has also been associated with endothelial dysfunction and coronary artery remodelling . In addition, patients with hypertrophic obstructive cardiomyopathy (HOCM) and an impaired micro vascular cardiac circulation assessed with PET, have been documented to have a poor prognosis . Also diastolic dysfunction as measured by Em/Am ratio during stress dobutamine echocardiography is related to CFR . Patients with Diabetes Mellitus have an impaired prognosis and longstanding disease influence microvascular physiology . Several methods have been utilized to assess micro vascular function including intracoronary Doppler measurements. CRF can now be assessed with transthoracic Doppler registration .
Several patients with angina and normal coronary arteries show persistence and even worsening of angina symptoms over time. . These patients constitute a therapeutic problem with considerable residual morbidity associated with functional limitation and reduced quality of life . The primary end point in the treatment of these patients is symptom control .
Reduced physical activity is one of the major avoidance behaviours in patients with coronary heart disease . On the other hand several studies have documented the positive effect of ET in this population . Psychological morbidity with great impact on daily living is well known in both patients with cardiovascular disease and in patients with chest pain with no obvious physical disease. This includes patients with CPNCA. These patients constitute a relatively large proportion of patients taken care of by the health authority system indicating that this issue has economic consequences for the society that is not neglectable2.
Exercise training (ET) has been shown to improve endothelial function in patients with coronary artery disease (CAD) and to reduce LVM in hypertension.. ET also improves endothelial dysfunction and reverse inflammation in CAD. It is also associated with improved outcome in the general population and in patients with CAD and heart failure. It has been documented that hs-CRP correlates with symptoms and ECG markers of myocardial ischemia in CPNCA patients . Whether hs-CRP is related to the pathogenesis of angina in these patients deserves further investigation. Whether ET may influence on pathological reduced CFR is currently not known.
Interventions proposed in CPNCA patients are directed at either improving microvascular function or decreasing chest pain perception, in an attempt to counteract the accepted pathophysiological mechanisms of the syndrome. A multidisciplinary approach and a genuine, sympathetic appreciation by the health staff of the devastating effect of cardiac syndrome X on the patients' quality of life usually have a positive therapeutic impact . Unfortunately, most treatments have been evaluated in small numbers of patients and/or in uncontrolled trials, thus making it difficult to establish their real degree of effectiveness. Tynni Lee 11 investigated the effects of physical training and relaxation therapy on exercise capacity and quality of life in patients with syndrome X. It is the first trial reported to assess the effect of physiotherapy intervention in terms of quality of life in patients with coronary syndrome X. Female patients with this syndrome benefit from physical training in terms of exercise capacity and quality of life, and from relaxation therapy in terms of quality of life. However a limitation is the small sample size and therefore non-significant findings may be due to an inability to detect a difference among groups. Further studies with larger number of patients are recommended. Different modes of physiotherapy could have the potential to break the vicious circle of effort-induced chest pain, functional limitations and poor quality of life in the patients with coronary syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingHigh intensity aerobic exercise training |
| No training | No intervention | –No exercise training, only ordinary daily life activities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- outpatients and patients admitted to the hospital with a history of repeated episodes of exercise induced chest pain.
- normal or near normal coronary angiogram or negative CT coronary angiogram
- age > 18 years
- being able to participate in training groups 3 times a week.
Key exclusion criteria (12 listed)
- serious valve disease
- cancer
- previous radiation or drug therapy for cancer
- musculoskeletal problems making ET impossible
- ongoing serious inflammatory 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 |
|---|---|---|
| Exercise traininghigh intensity aerobic interval training | Other | Exercise training |
Primary outcome
Coronary flow reserve
Time frame: 3 months
Changes of Cornary flow reserve following 3 months of exercise training
2 secondary outcomes
Endothelial function
Time frame: 3 months
Functional capacity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Derived from this study: PubMed 37113515Larsen AI, Saeland C, Vegsundvag J, Skadberg MS, Nilsen J, Butt N, Ushakova A, Valborgland T, Munk PS, Isaksen K. Aerobic high-intensity interval exercise training in patients with angina and no obstructive coronary artery disease: feasibility and physiological effects. Eur Heart J Open. 2023 Mar 22;3(2):oead030. doi: 10.1093/ehjopen/oead030. eCollection 2023 Mar.
- 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.
Alf Inge Larsen, MD, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Angina, run by Helse Stavanger HF at 1 site in Norway.
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 12 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 19 Sep 2016. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alf Inge Larsen, Md, PhD (004795889896, laai@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary flow reserve (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905630, which also lists 1 linked publication.
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 19 Sep 2016.