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

NCT ID: NCT06734247

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-24
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Coronary computer tomography angiography (CCTA)

Use of standard equipment for usual care

Intervention Type: DIAGNOSTIC_TEST

Photoplethysmography (PPG) and single-lead ECG

Physiological data acquisition equipment

Intervention Type: OTHER

Brachial single cuff-based arterial stiffness

Use of standard equipment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing coronary computer tomography angiography to investigate stable suspected symptomatic coronary artery disease.
• Age 30 to <70 years of age.

Exclusion Criteria

• Known coronary artery disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel).
• Known significant cardiac (> moderate valvular disease, heart failure with reduced ejection fraction, hypertrophic cardiomyopathy, or congenital heart disease), or pulmonary condition which could explain symptoms.
• Known ongoing atrial fibrillation/flutter.
• No Swedish social security number.
• Unable to provide written informed consent.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KTH Royal Institute of Technology

OTHER

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonas Spaak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Cardiovascular Medicine, Stockholm, Sweden

Locations

Danderyd University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Henrik Hellqvist, MD

Role: CONTACT

henrik.hellqvist@ki.se

+46812355000

Facility Contacts

Henrik Hellqvist, MD

Role: primary

henrik.hellqvist@ki.se

Other Identifiers

HW2

Identifier Type: -

Identifier Source: org_study_id