NCT06734247

Arterial Stiffness for Improved Prediction of Coronary Artery Disease by Coronary CT Angiography

Pulse Wave Velocity and Machine Learning for Prediction of Coronary Artery Disease by Coronary CT Angiography - The Heart Waves Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ability of device-estimated pulse wave velocity and machine learning methods to improve the prediction of potential symptomatic coronary artery disease

Detailed description

In stable patients with suspected symptomatic coronary artery disease, an estimation of pre-test probability (PTP) and a clinical assessment are used to decide who should be investigated further. PTP has historically been based on age, sex, the nature of chest pain or dyspnea as angina equivalent. It is recommended to continue investigation of all with PTP ≥15%, but also to consider investigation at PTP 5-15% (low-intermediate risk) which is the majority of patients. Despite updates to PTP estimations in the 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes, it has been shown that they overestimate the risk of coronary artery disease. In 2024, the ESC Guidelines were updated to recommend an updated clinical assessment method, the risk factor-weighted clinical likelihood (RF-CL), which is based on symtoms and number of risk factors. It has been shown to have better predictive ability compared to PTP alone, but is still largely based on epidemiological data, which may not be valid for all individuals. Coronary computer tomography angiography (CCTA) is the method becoming increasingly established at low-intermediate risk. An initial, non-invasive strategy with CCTA compared to invasive or more advanced examinations is safe and simple. At the same time, CCTA is resource-intensive, with limited availability, and the examination involves both contrast, radiation and incidental findings. Thus, there is a need to improve the risk estimation. Arterial stiffness assessed by pulse wave velocity is an independent marker for cardiovascular events and has been shown to be independently associated with the degree of coronary artery disease. Arterial stiffness is, however, rarely measured in the clinic as it traditionally has required cumbersome procedures. Newer methods include the brachial single cuff-based Arteriograph and the optical technique photoplethysmography (PPG), widely available in healthcare pulse oximeters, but increasingly also in different consumer devices, often complemented by single-lead ECG. The main aim of this study is to evaluate arterial stiffness and its possible role to improve risk stratification of patients undergoing CCTA for potential coronary artery disease.

Conditions

• Coronary Artery Disease
• Chest Pain
• Dyspnea
• Arterial Stiffness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary computer tomography angiography (CCTA)	Use of standard equipment for usual care
OTHER	Photoplethysmography (PPG) and single-lead ECG	Physiological data acquisition equipment
DEVICE	Brachial single cuff-based arterial stiffness	Use of standard equipment

Timeline

• Start date: 2023-10-24
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-12-16
• Last updated: 2026-04-17

Locations

1 site across 1 country: Sweden