Chronic Coronary Syndrome in Swedish Primary Care

NCT05782582 | Recruiting DMC

• 2 other identifiers: 2022-04416-01RÖ-961940
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Coronary Artery Disease

Keywords

Primary Health Care; Diagnostic Imaging; Myocardial Perfusion Imaging

Outcome Measures

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).

  From the day of inclusion up to one year

Secondary Outcomes (13)

• Swedish crowns or other currency

  From the day of inclusion and one year thereafter

• Health related quality of life

  Up to five years

• Radiation per patient

  One year

• Physical activity

  Up to five years

• Dietary habits

  Up to five years

Other Outcomes (6)

• Presence of pathological q-waves

  On the day of inclusion

• Reversible ischemia

  On the day of inclusion

• Alcohol consumption

  Up to five years

Study Arms (2)

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

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. ,

Diagnostic Test: Standard investigation

Interventions

Package investigation DIAGNOSTIC_TEST

Investigations performed on a single visit, according to arm description

Package investigation

Sound registration with Cadscore® and added risk calculation DEVICE

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

Package investigation

Standard investigation DIAGNOSTIC_TEST

Sequential investigations according to arm description

Standard investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Östergötland: lead
• Linkoeping University: collaborator

Study Sites (3)

Department of Clinical Physiology, Linköping University Hospital, Linköping

Linköping, S-58185, Sweden

RECRUITING

Hjärthälsan Linköping AB

Linköping, S-582 18, Sweden

RECRUITING

Department of Clinical Physiology, Vrinnevi Hospital

Norrköping, S-601 82, Sweden

RECRUITING

Related Publications (17)

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  PMID: 31504439 BACKGROUND

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  PMID: 40544312 DERIVED

Related Links

• SWEDEHEART
• The National Patient Register
• Dödsorsaksregistret (The Cause of Death Register)
• The National Prescribed Drug Register

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fredrik Iredahl, MD, PhD

  IMH/Community Medicine/Linkoping university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Iredahl, MD PhD

CONTACT

+46101030000; fredrik.iredahl@liu.se

Staffan Nilsson, MD, PhD

CONTACT

+46101030000; staffan.g.nilsson@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General practitioner, associate professor, principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 23, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)