Chronic Coronary Syndrome in Swedish Primary Care

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Sweden
Department of Clinical Physiology, Linköping University Hospital, Linköping
RECRUITING
Linköping
Hjärthälsan Linköping AB
RECRUITING
Linköping
Department of Clinical Physiology, Vrinnevi Hospital
RECRUITING
Norrköping
Contact Information
Primary
Fredrik Iredahl, MD PhD
fredrik.iredahl@liu.se
+46101030000
Backup
Staffan Nilsson, MD, PhD
staffan.g.nilsson@liu.se
+46101030000
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 500
Treatments
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
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.~,
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University
Leads: Region Östergötland

This content was sourced from clinicaltrials.gov