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

NCT06734247 | Terminated

• 1 other identifier: HW2
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Chest Pain; Dyspnea; Arterial Stiffness

Keywords

PPG; Machine Learning; Pulse Wave Velocity; Arterial Stiffness; CAD-RADS; CACS

Outcome Measures

Primary Outcomes (1)

• Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥3

  Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥3 when adding photoplethysmography (PPG) estimated arterial stiffness to the standard model (including age, sex, symtom score \[0-3\] and number of risk factors \[0-5\]). Coronary artery disease reporting and data system (CAD-RADS) ≥3 refers to the classification of coronary artery disease with at least moderate stenosis as identified on coronary computer tomography angiography. The classification follows the CAD-RADS 2.0 definition. Stenosis is graded in severity from 0-5.

  Typically within 1 month of enrollment

Secondary Outcomes (9)

• Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥2

  Typically within 1 month of enrollment

• Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥3 by Arterigraph

  Typically within 1 month of enrollment

• Improved area under receiver operating curve (ROC) to predict CAD-RADS ≥2 by Arterigraph

  Typically within 1 month of enrollment

• Improved area under receiver operating curve (ROC) to predict Coronary artery calcium score

  Typically within 1 month of enrollment

• Number of patients diagnosed with acute or chronic coronary artery disease

  1 year after enrollment

Interventions

Photoplethysmography (PPG) and single-lead ECG OTHER

Physiological data acquisition equipment

Brachial single cuff-based arterial stiffness DEVICE

Use of standard equipment

Coronary computer tomography angiography (CCTA) DIAGNOSTIC_TEST

Use of standard equipment for usual care

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing coronary CTA to investigate potential symptomatic coronary artery disease

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danderyd Hospital: lead
• KTH Royal Institute of Technology: collaborator

Study Sites (1)

Danderyd University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Coronary Artery Disease; Chest Pain; Dyspnea

Interventions

serglycin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Jonas Spaak, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: December 16, 2024
• Study Start: October 24, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

SE (1)