Chronic Coronary Syndrome in Swedish Primary Care

NCT ID: NCT05782582

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Package investigation

Intervention Type: DIAGNOSTIC_TEST

Investigations performed on a single visit, according to arm description

Sound registration with Cadscore® and added risk calculation

Intervention Type: DEVICE

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

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.

,

Group Type: ACTIVE_COMPARATOR

Standard investigation

Intervention Type: DIAGNOSTIC_TEST

Sequential investigations according to arm description

Interventions

Package investigation

Investigations performed on a single visit, according to arm description

Intervention Type: DIAGNOSTIC_TEST

Sound registration with Cadscore® and added risk calculation

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

Intervention Type: DEVICE

Standard investigation

Sequential investigations according to arm description

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Region Östergötland

OTHER

Sponsor Role: lead

Responsible Party

Staffan Nilsson

General practitioner, associate professor, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Iredahl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IMH/Community Medicine/Linkoping university

Locations

Department of Clinical Physiology, Linköping University Hospital, Linköping

Linköping, , Sweden

Site Status: RECRUITING

Hjärthälsan Linköping AB

Linköping, , Sweden

Site Status: RECRUITING

Department of Clinical Physiology, Vrinnevi Hospital

Norrköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Fredrik Iredahl, MD PhD

Role: CONTACT

fredrik.iredahl@liu.se

+46101030000

Staffan Nilsson, MD, PhD

Role: CONTACT

staffan.g.nilsson@liu.se

+46101030000

Facility Contacts

Jan Engvall, Professor

Role: primary

jan.engvall@liu.se

Carlos Valadares, MD

Role: primary

kontakt@hhalsan.se

Karin Pejic, MD

Role: primary

Karin.Pejic@regionostergotland.se

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.ucr.uu.se/swedeheart/

SWEDEHEART

https://www.socialstyrelsen.se/en/statistics-and-data/registers/national-patient-register/

The National Patient Register

https://www.socialstyrelsen.se/statistik-och-data/register/dodsorsaksregistret/

Dödsorsaksregistret (The Cause of Death Register)

https://www.socialstyrelsen.se/en/statistics-and-data/registers/national-prescribed-drug-register/

The National Prescribed Drug Register

Other Identifiers

2022-04416-01

Identifier Type: -

Identifier Source: org_study_id

RÖ-961940

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id