Chronic Coronary Syndrome in Swedish Primary Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Östergötland

About this trial

The goal of this clinical trial is to learn about a new procedure for investigation of possible coronary heart disease and to see if it is faster, cheaper or more expensive, promotes healthier behavior, mental well-being, adherence to drugs for heart protection and the risk for cardiac events like acute myocardial infarction over years to come. The novelty in the procedure is that a myocardial perfusion scan to assess blood flow to areas of the heart muscle, echocardiography i.e., heart ultrasound and heart CT scan comes as a "package investigation" performed on the same day. According to existing routines, "standard investigation" an exercise stress bicycle test is done, as well as an echocardiography and if needed the work up is completed by a myocardial perfusion scan. The main questions the trial aims to answer are:

* are the results from the procedure given to the patient faster with package investigation as compared to standard investigation? * does the cost differ between the package and standard investigation group? * does self-reported physical activity, physical fitness, dietary habits and mental well-being differ between the package and standard investigation group at start and after one, three and five years? * does prescription of drugs taken for heart protection and adherence to the prescribed drugs differ between the package and standard investigation group after two and five years? * does the risk for heart events like acute heart infarction differ between package and standard investigation after two and five years?

Primary health care centers in Region Östergötland are randomly assigned to use either the new or existing procedure for investigation of possible coronary heart disease a so called cluster randomization. Patients who consult a physician at any of these primary health care centers are potential participants in the trial and are informed about the trial by written information, as they get their appointment for the medical investigation at either of two hospitals in the Region Östergötland. When the patient comes to the hospital for the investigations, he or she is asked to give written consent to the research i.e., to answer questionnaires now after one, three and five years, to let the researchers take part of the medical records, investigational results and data from medical registries over time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Suspicion of acute coronary syndrome when care is sought.

Previously diagnosed acute myocardial infarction

Revascularization with PCI/CABG

Proven reversible ischemia according to myocardial scintigraphy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Package investigation

    Diagnostic test

    Investigations performed on a single visit, according to arm description

  • Sound registration with Cadscore® and added risk calculation

    Device

    Recording of cardiac diastolic sounds enabling the calculation of a risk score.

  • Standard investigation

    Diagnostic test

    Sequential investigations according to arm description

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Package investigationExperimental treatment 2 interventions
Group B: Standard investigationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of days till completed assessment of myocardial ischemia

waiting time (days) after the results of package investigation or exercise stress bicycle test (standard investigation) are available at the primary health care center till invasive coronary angiography is done or results from completed non-invasive myocardial ischemia investigation is communicated to the participant (patient).

Time frame
From the day of inclusion up to one year

Secondary outcomes

1

Swedish crowns or other currency

Costs for medical investigations, consultations and costs generated by participants loss of production and travel costs. Data will be gathered by review of the participants computerized medical records one year after the day of inclusion. Medical investigations will be sought in local medical registries.The participant will be asked if being a professional worker or not on the day of inclusion.

Time frame
From the day of inclusion and one year thereafter
2

Health related quality of life

Health related quality of life will be measured by EQ-5D-5L Swedish version (Devlin NJ et al., 2017)

Time frame
Up to five years
3

Radiation per patient

millisievert (mSv)

Time frame
One year
4

Physical activity

Physical activity will be measured by two categorical questions asking for level of physical activity (Olsson SJ et al., 2016)

Time frame
Up to five years

Other outcomes

1

Presence of pathological q-waves

Resting ECG

Time frame
On the day of inclusion
2

Reversible ischemia

ST-depression provoked by exercise

Time frame
On the day of inclusion
3

Alcohol consumption

Alcohol consumption will be measured by the Alcohol Use Disorders Identification Test - AUDIT. Score range: 0-40. (WHO-publications 2001)

Time frame
Up to five years
4

Smoking

Smoking will be measured by the question 'Do you smoke?' (No, I have never smoked/No, I have quitted/Yes, occasionally/Yes, daily) and quantified by the number of cigarettes per day.

Time frame
Up to five years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Östergötland

Lead sponsor

Linkoeping University

Collaborator