Chronic Coronary Syndrome in Swedish Primary Care

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

Interventions

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.

DIAGNOSTIC_TEST

Standard investigation

Sequential investigations according to arm description

Sponsors & Collaborators

• Linkoeping University

  collaborator OTHER_GOV

• Region Östergötland

  lead OTHER

Principal Investigators

• Fredrik Iredahl, MD, PhD · IMH/Community Medicine/Linkoping university

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-01

Primary Completion

2027-12-31

Completion

2032-12-31

Countries

• Sweden

Study Locations