Personalized Evaluation of Susptected Myocardial Ischemia

Condition(s) studied

Investigational drug(s) / intervention(s)

Clinical Likelihood (CL) Model-Based Diagnostic Strategy: The Clinical Likelihood (CL) model-based diagnostic strategy utilizes two models: the RF-CL model and the CACS-CL model. These models assess the pre-test probability of obstructive coronary artery disease (CAD) based on patient factors such as age, sex, symptoms, and traditional cardiovascular risk factors like smoking, diabetes, and hypertension. The CACS-CL model incorporates coronary artery calcium scoring to further refine the risk assessment. Patients identified with a low likelihood of CAD may avoid unnecessary diagnostic testing, such as cardiac CT, while maintaining diagnostic accuracy and safety. This approach aims to optimize resource use, reduce patient burden, and focus on other potential causes of symptoms when CAD is unlikely.

Standard of care treatment: Patients will follow the standard diagnostic pathway, which includes the use of cardiac CT and other advanced diagnostic procedures based on clinical guidelines. This approach is the current standard of care for patients with suspected obstructive coronary artery disease (CAD). The control group allows for comparison of outcomes with those in the intervention arm, particularly in terms of resource utilization, patient safety, and diagnostic accuracy.

Study summary

This study aims to assess whether the use of clinical risk models, known as Clinical Likelihood (CL) models, can reduce the need for diagnostic examinations without negatively impacting quality of life or prognosis after 12 months in patients with stable new onset chest pain. Additionally, the project will evaluate a newly developed method called Laser Speckle Contrast Imaging for measuring function and oxygen content in the smallest blood vessels (microvasculature) of the hand, which may also reflect blood flow and oxygen content in the microvasculature of the heart.

Eligibility

Primary outcome measure(s)

• Proportion of Asymptomatic Patients 6 Months After Inclusion — From enrollment to 6 months after patient inclusion
  Resolution 6 months after inclusion, as assessed by SAQ Angina Frequency score of 100%, indicating the absence of angina-related symptoms. This measure will assess the effectiveness of a diagnostic strategy based on Clinical Likelihood (CL) models compared to the standard approach for evaluating patients suspected of stable ischemic heart disease (IHD).

Trial sites (1)

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