# Chronic cOronary Syndrome in Swedish PRImary care (COSPRI)—a study protocol for a 5-year cluster randomized controlled trial on a novel package versus standard investigation in patients with suspected chronic coronary syndrome referred from primary health care

## TL;DR

This study compares a new diagnostic package for heart disease in primary care to the standard approach, aiming to speed up diagnosis and improve outcomes.

## Contribution

The study introduces a novel diagnostic package including CAC scoring and acoustic risk assessment in primary care for chronic coronary syndrome.

## Key findings

- The trial will assess if the new diagnostic package reduces waiting times for invasive procedures or test results.
- It explores whether the novel approach improves risk assessment and reduces specialist consultations.
- The study will evaluate the cost-effectiveness and safety of the new diagnostic strategy.

## Abstract

This trial aims to assess the effectiveness of a novel diagnostic package in the investigation of symptomatic chronic coronary artery disease (CAD), with a focus on reducing the time to diagnosis and improving risk assessment, compared to the current standard investigation approach. The package investigation is comprised of combined single photon emission computed tomography (SPECT), echocardiography, coronary artery calcification (CAC) scoring, not previously evaluated in Sweden for individual cardiovascular prevention, and CadScore, an acoustic risk score. The standard investigation is comprised of exercise bicycle stress testing and echocardiography.

The trial involves patients with a pre-test probability > 15% for significant CAD referred from primary healthcare centers (PHCs) in Region Östergötland (population 471,241 in March 2023) in south-east Sweden. All the 47 PHCs of the region will be invited to participate and will, after approval, be cluster randomized into two groups: package investigation versus standard investigation. The primary outcome is a composite measure comprised of waiting time to invasive coronary angiography or communication of non-invasive myocardial ischemia investigation results. Secondary outcomes include major adverse cardiovascular events (MACE), cost per patient, signs of reversible ischemia on any test, radiation exposure, and adherence to prescribed cardioprotective drugs.

This trial addresses the urgent problem of chest pain and dyspnea assessment in primary care and aims to speed up diagnosis, reduce the need for specialist consultations, and potentially improve patient outcomes, with referral to SPECT directly from PHC in comparison with the widely used exercise test. The novel approach includes CAC scoring. Additionally, the utility of acoustic CadScore in reclassifying the risk of CAD is explored.

Trial registration.

The trial was registered on March 11, 2023, at ClinicalTrials.gov with the identifier: NCT05782582.