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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Package investigation
Diagnostic testInvestigations performed on a single visit, according to arm description
Sound registration with Cadscore® and added risk calculation
DeviceRecording of cardiac diastolic sounds enabling the calculation of a risk score.
Standard investigation
Diagnostic testSequential investigations according to arm description
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Health related quality of life
Health related quality of life will be measured by EQ-5D-5L Swedish version (Devlin NJ et al., 2017)
Radiation per patient
millisievert (mSv)
Physical activity
Physical activity will be measured by two categorical questions asking for level of physical activity (Olsson SJ et al., 2016)
Other outcomes
Presence of pathological q-waves
Resting ECG
Reversible ischemia
ST-depression provoked by exercise
Alcohol consumption
Alcohol consumption will be measured by the Alcohol Use Disorders Identification Test - AUDIT. Score range: 0-40. (WHO-publications 2001)
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.
Sponsors and contacts
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Region Östergötland
Lead sponsor
Linkoeping University
Collaborator