Coronary Artery DiseaseCOSPRINCT05782582
Chronic Coronary Syndrome in Swedish Primary Care
A study testing Package investigation, Sound registration with Cadscore® and added risk calculation and Standard investigation in people with Coronary Artery Disease, run by Region Östergötland at 3 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Package investigation, Sound registration with Cadscore® and added risk calculation and Standard investigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesSweden
- Study dates
- 1 May 2023to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who seek primary care for symptoms judged to be compatible with a medium probability (PTP> 15) for symptomatic chronic coronary artery disease.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Department of Clinical Physiology, Linköping University Hospital, Linköping
Linköping, S-58185
Jan Engvall, Professor, jan.engvall@liu.se
- Recruiting
Hjärthälsan Linköping AB
Linköping, S-582 18
Carlos Valadares, MD, kontakt@hhalsan.se
- Recruiting
Department of Clinical Physiology, Vrinnevi Hospital
Norrköping, S-601 82
Karin Pejic, MD, Karin.Pejic@regionostergotland.se
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Package investigation, Sound registration with Cadscore® and added risk calculation, Standard investigation
- Keywords
- Primary Health Care, Diagnostic Imaging, Myocardial Perfusion Imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package investigationDiagnostic test
Investigations performed on a single visit, according to arm description
Sound registration with Cadscore® and added risk calculationDevice
Recording of cardiac diastolic sounds enabling the calculation of a risk score.
Standard investigationDiagnostic test
Sequential investigations according to arm description
| Study group | Role | What they receive |
|---|---|---|
| Package investigation | Experimental | 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 Receives: Diagnostic Test: Package investigation; Device: Sound registration with Cadscore® and added risk calculation |
| Standard investigation | Active comparator | 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.
, Receives: Diagnostic Test: Standard investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the day of inclusion up to one year
Secondary outcomes (13)
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.
Measured: From the day of inclusion and one year thereafter
Health related quality of life
Health related quality of life will be measured by EQ-5D-5L Swedish version (Devlin NJ et al., 2017)
Measured: Up to five years
Radiation per patient
millisievert (mSv)
Measured: One year
Physical activity
Physical activity will be measured by two categorical questions asking for level of physical activity (Olsson SJ et al., 2016)
Measured: Up to five years
Dietary habits
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)
Measured: Up to five years
Health and life quality
Health and life quality will be measured by the Swedish RAND-36 A 36-item scale. (Ohlsson-Nevo E et al., 2021)
Measured: Up to five years
Heart focused anxiety
Heart focused anxiety will be measured by the Cardiac Anxiety Questionnaire - CAQ An 18-item scale (Eifert et al., 2000)
Measured: Up to five years
Generalized anxiety
Generalized anxiety will be measured by the Brief Measure for Assessing Generalized Anxiety Disorder - GAD-7 A seven item scale. (Spitzer et al., 2006)
Measured: Up to five years
Depression symptoms
Depression symptoms will be measured by the Patient Health Questionnaire - PHQ-9 Maximum score 27 (Hansson et al., 2009)
Measured: Up to five years
Sleep quality
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)
Measured: Up to five years
Physical fitnes
Physical fitness will be measured by The International Fitness Scale - IFIS A 5-item scale (Ortega FB et al., 2011)
Measured: Up to five years
MACE
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)
Measured: Up to five years
Compliance to cardioprotective drugs
Data on prescribed and purchased drugs will be gathered from the National Prescribed Drug Register .
Measured: Two years before and up to five years after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 May 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial. All of 47 primary health care centres in Region Östergötland are invited to take part. After acceptance the actual number of primary health care centres will be randomly allocated to to either package or standard investigation group. The aim is to include about 20 primary health care centers in the study.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Staffan Nilsson, Region Östergötland
- Investigators
- Fredrik Iredahl, MD, PhD, Principal investigator, IMH/Community Medicine/Linkoping university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782582
- Sponsor's protocol ID
- 2022-04416-01
- Other IDs
- RÖ-961940
- Acronym
- COSPRI
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Hoorweg BB, Willemsen RT, Cleef LE, Boogaerts T, Buntinx F, Glatz JF, Dinant GJ. Frequency of chest pain in primary care, diagnostic tests performed and final diagnoses. Heart. 2017 Nov;103(21):1727-1732. doi: 10.1136/heartjnl-2016-310905. Epub 2017 Jun 20.
PubMed 28634285Knuuti J, Ballo H, Juarez-Orozco LE, Saraste A, Kolh P, Rutjes AWS, Juni P, Windecker S, Bax JJ, Wijns W. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018 Sep 14;39(35):3322-3330. doi: 10.1093/eurheartj/ehy267.
PubMed 29850808Juarez-Orozco LE, Saraste A, Capodanno D, Prescott E, Ballo H, Bax JJ, Wijns W, Knuuti J. Impact of a decreasing pre-test probability on the performance of diagnostic tests for coronary artery disease. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1198-1207. doi: 10.1093/ehjci/jez054.
PubMed 30982851Winther S, Nissen L, Schmidt SE, Westra JS, Rasmussen LD, Knudsen LL, Madsen LH, Kirk Johansen J, Larsen BS, Struijk JJ, Frost L, Holm NR, Christiansen EH, Botker HE, Bottcher M. Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification. Heart. 2018 Jun;104(11):928-935. doi: 10.1136/heartjnl-2017-311944. Epub 2017 Nov 9.
PubMed 29122932Budoff MJ, Young R, Burke G, Jeffrey Carr J, Detrano RC, Folsom AR, Kronmal R, Lima JAC, Liu KJ, McClelland RL, Michos E, Post WS, Shea S, Watson KE, Wong ND. Ten-year association of coronary artery calcium with atherosclerotic cardiovascular disease (ASCVD) events: the multi-ethnic study of atherosclerosis (MESA). Eur Heart J. 2018 Jul 1;39(25):2401-2408. doi: 10.1093/eurheartj/ehy217.
PubMed 29688297Mitchell JD, Fergestrom N, Gage BF, Paisley R, Moon P, Novak E, Cheezum M, Shaw LJ, Villines TC. Impact of Statins on Cardiovascular Outcomes Following Coronary Artery Calcium Scoring. J Am Coll Cardiol. 2018 Dec 25;72(25):3233-3242. doi: 10.1016/j.jacc.2018.09.051.
PubMed 30409567Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
PubMed 28194657Olsson SJ, Ekblom O, Andersson E, Borjesson M, Kallings LV. Categorical answer modes provide superior validity to open answers when asking for level of physical activity: A cross-sectional study. Scand J Public Health. 2016 Feb;44(1):70-6. doi: 10.1177/1403494815602830. Epub 2015 Sep 21.
PubMed 26392418Henriksson H, Alexandrou C, Henriksson P, Henstrom M, Bendtsen M, Thomas K, Mussener U, Nilsen P, Lof M. MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. BMC Public Health. 2020 Nov 23;20(1):1756. doi: 10.1186/s12889-020-09808-w.
PubMed 33228572Ohlsson-Nevo E, Hiyoshi A, Noren P, Moller M, Karlsson J. The Swedish RAND-36: psychometric characteristics and reference data from the Mid-Swed Health Survey. J Patient Rep Outcomes. 2021 Aug 4;5(1):66. doi: 10.1186/s41687-021-00331-z.
PubMed 34347192Eifert GH, Thompson RN, Zvolensky MJ, Edwards K, Frazer NL, Haddad JW, Davig J. The cardiac anxiety questionnaire: development and preliminary validity. Behav Res Ther. 2000 Oct;38(10):1039-53. doi: 10.1016/s0005-7967(99)00132-1.
PubMed 11004742Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Hansson M, Chotai J, Nordstom A, Bodlund O. Comparison of two self-rating scales to detect depression: HADS and PHQ-9. Br J Gen Pract. 2009 Sep;59(566):e283-8. doi: 10.3399/bjgp09X454070.
PubMed 19761655Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Coronary Syndrome in Swedish Primary Care
- ClinicalTrials.gov ID
- NCT05782582
- Acronym / sponsor ID
- COSPRI / 2022-04416-01
- Conditions
- Coronary Artery Disease
- Keywords
- Primary Health Care, Diagnostic Imaging, Myocardial Perfusion Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 23 Mar 2023 (actual)
- 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.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised trial. All of 47 primary health care centres in Region Östergötland are invited to take part. After acceptance the actual number of primary health care centres will be randomly allocated to to either package or standard investigation group. The aim is to include about 20 primary health care centers in the study.
| Arm | Type | Receives |
|---|---|---|
| Package investigation | Experimental | Diagnostic Test: Package investigation, Device: Sound registration with Cadscore® and added risk calculation1. 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 |
| Standard investigation | Active comparator | Diagnostic Test: Standard investigation1. 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. , |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who seek primary care for symptoms judged to be compatible with a medium probability (PTP> 15) for symptomatic chronic coronary artery disease.
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| Package investigationInvestigations performed on a single visit, according to arm description | Diagnostic test | Package investigation |
| Sound registration with Cadscore® and added risk calculationRecording of cardiac diastolic sounds enabling the calculation of a risk score. | Device | Package investigation |
| Standard investigationSequential investigations according to arm description | Diagnostic test | Standard investigation |
Primary outcome
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).
13 secondary outcomes
Swedish crowns or other currency
Time frame: From the day of inclusion and one year thereafter
Health related quality of life
Time frame: Up to five years
Radiation per patient
Time frame: One year
Physical activity
Time frame: Up to five years
Dietary habits
Time frame: Up to five years
Health and life quality
Time frame: Up to five years
Heart focused anxiety
Time frame: Up to five years
Generalized anxiety
Time frame: Up to five years
Depression symptoms
Time frame: Up to five years
Sleep quality
Time frame: Up to five years
Physical fitnes
Time frame: Up to five years
MACE
Time frame: Up to five years
Compliance to cardioprotective drugs
Time frame: Two years before and up to five years after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
- Background: PubMed 28634285Hoorweg BB, Willemsen RT, Cleef LE, Boogaerts T, Buntinx F, Glatz JF, Dinant GJ. Frequency of chest pain in primary care, diagnostic tests performed and final diagnoses. Heart. 2017 Nov;103(21):1727-1732. doi: 10.1136/heartjnl-2016-310905. Epub 2017 Jun 20.
- Background: PubMed 29850808Knuuti J, Ballo H, Juarez-Orozco LE, Saraste A, Kolh P, Rutjes AWS, Juni P, Windecker S, Bax JJ, Wijns W. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018 Sep 14;39(35):3322-3330. doi: 10.1093/eurheartj/ehy267.
- Background: PubMed 30982851Juarez-Orozco LE, Saraste A, Capodanno D, Prescott E, Ballo H, Bax JJ, Wijns W, Knuuti J. Impact of a decreasing pre-test probability on the performance of diagnostic tests for coronary artery disease. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1198-1207. doi: 10.1093/ehjci/jez054.
- Background: PubMed 29122932Winther S, Nissen L, Schmidt SE, Westra JS, Rasmussen LD, Knudsen LL, Madsen LH, Kirk Johansen J, Larsen BS, Struijk JJ, Frost L, Holm NR, Christiansen EH, Botker HE, Bottcher M. Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification. Heart. 2018 Jun;104(11):928-935. doi: 10.1136/heartjnl-2017-311944. Epub 2017 Nov 9.
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- Background: PubMed 30409567Mitchell JD, Fergestrom N, Gage BF, Paisley R, Moon P, Novak E, Cheezum M, Shaw LJ, Villines TC. Impact of Statins on Cardiovascular Outcomes Following Coronary Artery Calcium Scoring. J Am Coll Cardiol. 2018 Dec 25;72(25):3233-3242. doi: 10.1016/j.jacc.2018.09.051.
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- Background: PubMed 33228572Henriksson H, Alexandrou C, Henriksson P, Henstrom M, Bendtsen M, Thomas K, Mussener U, Nilsen P, Lof M. MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study. BMC Public Health. 2020 Nov 23;20(1):1756. doi: 10.1186/s12889-020-09808-w.
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- SWEDEHEARTLink provided by the sponsor.
- The National Patient RegisterLink provided by the sponsor.
- Dödsorsaksregistret (The Cause of Death Register)Link provided by the sponsor.
- The National Prescribed Drug RegisterLink provided by the sponsor.
- 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.
Fredrik Iredahl, MD, PhD principal investigator
IMH/Community Medicine/Linkoping university
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Package investigation, Sound registration with Cadscore® and added risk calculation and Standard investigation in people with Coronary Artery Disease, run by Region Östergötland at 3 sites in Sweden.
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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Iredahl, MD PhD (+46101030000, fredrik.iredahl@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days till completed assessment of myocardial ischemia (time frame: From the day of inclusion up to one year). 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 NCT05782582, which also lists 17 linked publications.
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 30 Jan 2026.