Chronic Coronary Syndrome in Swedish Primary Care (COSPRI)

January 28, 2026 updated by: Staffan Nilsson, Region Östergötland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In primary health care patients with chest symptoms are common. In many cases the cause is benign but chronic coronary artery disease (CAD) must often be considered. In the clinical work, evaluation of symptoms and risk factors are fundamental for a plausible working diagnosis and to judge if any further investigation is needed. The probability of CAD for a person of a certain age, sex and character of chest symptoms, scored from 0-3, i.e. pretest probability (PTP) for CAD, is substantially lower now than it was a decade ago in western countries. Consequently, recent European guidelines recommend that further investigation to rule out CAD may be omitted if the risk for CAD is judged to be low (PTP<15 %) and there are no further cardiovascular risk factors. If further investigation is needed in the low-risk group, computed tomography angiography (CTA) is preferable. When the risk for CAD is judged to be intermediate (PTP> 15 %) an imaging investigation is advocated instead of the well-established exercise stress bicycle test. A much-used imaging test is myocardial perfusion scan in which an exercise stress bicycle test is performed, with the addition of an intravenous injection of a small amount of radioactive tracer, whereafter the myocardial blood flow is demonstrated by imaging. Sensitivity for myocardial perfusion scan to detect significant CAD is 87 % (95 % CI 83-90) in comparison with exercise stress bicycle test where it is only 58 % (95 % CI 46-69). Specificity is 70 % (95 % CI 63-76) and 62 (95 % CI 54-69) respectively. However, the exercise stress bicycle test reveals indirect signs of myocardial ischemia and is reasonable in price, easy to perform and available in many clinics and hospitals. It is since long the first-line method for referral from the primary care setting. If the result from the exercise stress bicycle test is inconclusive, the work-up should be continued, e.g. with myocardial perfusion scan. An echocardiogram is often performed as well to evaluate the condition of the myocardium, heart valves and left ventricular ejection fraction. This stepwise or sequential clinical work-up strategy is well known and reasonable in general practice where patients in general have a low prevalence of serious diseases compared to organ specialist clinics. Since June 2021 in Region Östergötland (471 912 inhabitants 2022) CTA is recommended if further investigation is deemed necessary in patients with a low risk of CAD (PTP< 15 %) in primary care. For patients with intermediate risk of CAD (PTP> 15 %) exercise stress bicycle test is still the first-line choice.

There may be advantages if myocardial perfusion scan and echocardiogram is performed on a single visit. In addition, a CT scan of the heart to determine coronary artery calcification (CAC) score is easy to perform on the same visit, gives only a small amount of radiation and adds useful information. The CAC-score has been shown to be an independent predictor of future cardiovascular events and is useful for reclassification of cardiovascular risk based on traditional risk factors like age, cholesterol levels and smoking habits. Furthermore, a clear and coherent answer on all three investigations, to the referring GP can provide a more secure basis for clinical decision making. For the individual patient it is probably an advantage to get a thorough investigation done at one single visit and possibly a faster and more valid statement from the investigations by the GP. On the other hand, if many advanced investigations are done unnecessarily, expenses and exposure to radiation will increase unjustifiably. Possibly there is also a risk of medicalization and to create worries for future cardiovascular events communicating the CAC-score to people that has not asked for the information.

In order to get a faster and more complete basis for the evaluation of CAD in primary care patients with an intermediate (PTP> 15 %) risk the investigators created a package investigation comprised of myocardial perfusion scan, echocardiogram and CT scan of the heart on a single visit. The results from myocardial perfusion scan will be written according to national guidelines and communicated to the referring GP together with results from echocardiogram and CAC-scoring as a coherent answer. Moreover, registration of heart sounds followed by risk calculation by a technical device Cadscore® will be performed but only for scientific analyzes and not be given as a clinical answer.

In this study the investigators aim to compare the standard routine sequential investigation for detecting CAD with a single-visit package investigation.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Linköping, Sweden, S-58185
        • Recruiting
        • Department of Clinical Physiology, Linköping University Hospital, Linköping
        • Contact:
      • Linköping, Sweden, S-582 18
        • Recruiting
        • Hjärthälsan Linköping AB
        • Contact:
      • Norrköping, Sweden, S-601 82

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• People who seek primary care for symptoms judged to be compatible with a medium probability (PTP> 15) for symptomatic chronic coronary artery disease.

Exclusion Criteria:

  • 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.
  • Left Bundle Branch Block (LBBB).
  • Ventricular pacemaker
  • People whose meaning due to illness, mental disorder, weakened state of health or any other similar condition cannot be obtained, to be included in a research project.
  • Insufficient understanding of spoken and written Swedish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Package investigation
  1. Resting ECG,
  2. Evaluation of risk according to PTP-table.
  3. Echocardiography,
  4. Exercise stress bicycle test (secondarily drug provocation) with injection of isotope for myocardial scintigraphy,
  5. Scanning for myocardial perfusion
  6. CAC-scoring with CT
Diagnostic test: Package investigation
Investigations performed on a single visit, according to arm description
Device: Sound registration with Cadscore® and added risk calculation
Recording of cardiac diastolic sounds enabling the calculation of a risk score.
Active Comparator: Standard investigation
  1. Resting ECG
  2. Evaluation of risk according to PTP-table.
  3. Echocardiography.
  4. Exercise stress bicycle test.

If judged to be needed according to clinical indication sequentially completed by:

Echocardiography, Exercise stress bicycle test (secondarily drug provocation) with injection of isotope for myocardial scintigraphy and/or Coronary CTA. In addition, cardiac examinations done with other modalities chosen on clinical grounds will be examined in the study.

,
Diagnostic test: Standard investigation
Sequential investigations according to arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days till completed assessment of myocardial ischemia
Time Frame: From the day of inclusion up to one year
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).
From the day of inclusion up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: Up to five years
Health related quality of life will be measured by EQ-5D-5L Swedish version (Devlin NJ et al., 2017)
Up to five years
Radiation per patient
Time Frame: One year
millisievert (mSv)
One year
Physical activity
Time Frame: Up to five years
Physical activity will be measured by two categorical questions asking for level of physical activity (Olsson SJ et al., 2016)
Up to five years
Dietary habits
Time Frame: Up to five years
Dietary habits will be measured by five categorical questions about consumption of fruit, vegetables, snacks and soft drinks during the last week. (Henriksson H et al., 2020)
Up to five years
Health and life quality
Time Frame: Up to five years
Health and life quality will be measured by the Swedish RAND-36 A 36-item scale. (Ohlsson-Nevo E et al., 2021)
Up to five years
Heart focused anxiety
Time Frame: Up to five years
Heart focused anxiety will be measured by the Cardiac Anxiety Questionnaire - CAQ An 18-item scale (Eifert et al., 2000)
Up to five years
Generalized anxiety
Time Frame: Up to five years
Generalized anxiety will be measured by the Brief Measure for Assessing Generalized Anxiety Disorder - GAD-7 A seven item scale. (Spitzer et al., 2006)
Up to five years
Depression symptoms
Time Frame: Up to five years
Depression symptoms will be measured by the Patient Health Questionnaire - PHQ-9 Maximum score 27 (Hansson et al., 2009)
Up to five years
Sleep quality
Time Frame: Up to five years
Sleep quality will be measured by The Pittsburgh Sleep Quality Index - PSQI A 19-item scale which assesses sleep quality and disturbances over a 1-month time interval. (Buysse et al., 1989)
Up to five years
Physical fitnes
Time Frame: Up to five years
Physical fitness will be measured by The International Fitness Scale - IFIS A 5-item scale (Ortega FB et al., 2011)
Up to five years
MACE
Time Frame: Up to five years
Major adverse cardiovascular event - MACE Data will be gathered from national Swedish registries i.e. SWEDEHEART, the National Patient Register and Dödsorsaksregistret (The Cause of Death Register)
Up to five years
Compliance to cardioprotective drugs
Time Frame: Two years before and up to five years after inclusion.
Data on prescribed and purchased drugs will be gathered from the National Prescribed Drug Register .
Two years before and up to five years after inclusion.
Swedish crowns or other currency
Time Frame: From the day of inclusion and one year thereafter
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.
From the day of inclusion and one year thereafter

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of pathological q-waves
Time Frame: On the day of inclusion
Resting ECG
On the day of inclusion
Reversible ischemia
Time Frame: On the day of inclusion
ST-depression provoked by exercise
On the day of inclusion
Alcohol consumption
Time Frame: Up to five years
Alcohol consumption will be measured by the Alcohol Use Disorders Identification Test - AUDIT. Score range: 0-40. (WHO-publications 2001)
Up to five years
Smoking
Time Frame: Up to five years
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.
Up to five years
Dental health
Time Frame: Up to five years
Dental health will be explored by a 5-item questionnaire constructed for the study
Up to five years
Number of days on sick leave
Time Frame: Time frame: From the day of inclusion and one year thereafter
Data will be gathered by review of the participants computerized medical records one year after the day of inclusion.
Time frame: From the day of inclusion and one year thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Östergötland

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Fredrik Iredahl, MD, PhD, IMH/Community Medicine/Linkoping university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 11, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-04416-01
  • RÖ-961940 (Other Grant/Funding Number: ALF Grants Region, Östergötland)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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