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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Alf Inge Larsen, Md, PhD contact

004795889896

laai@sus.no

Norway1 site, 1 recruiting
  • Stavanger University Hospital

    Stavanger, 4068

    Alf Inge Larsen, MD, PhD, +4751513201, laai@sus.no

    Recruiting

Other trials in Norway

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.

Study groups in NCT02905630
Study groupRoleWhat they receive
Exercise trainingExperimentalHigh intensity aerobic exercise training
Receives: Other: Exercise training
No trainingNo interventionNo exercise training, only ordinary daily life activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary flow reserve

    Changes of Cornary flow reserve following 3 months of exercise training

    Measured: 3 months

Secondary outcomes (2)
  1. Endothelial function

    Arterial diameter after occlusion at baseline and at 3 months follow up

    Measured: 3 months

  2. 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.

  1. First posted19 Sep 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

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)
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

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.

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