Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease

NCT06183294 | Completed

• 1 other identifier: 808066
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the AutocathFFR software to assess if invasive FFR measurements and automated computer analysis of FFR measurements correlate. AutocathFFR measurement per lesion will be compared to the gold standard, invasive FFR value, where an FFR ≤ 0.80 will be considered "positive", while an FFR \> 0.8 will be considered "negative". The AutocathFFR value will be compared to the invasive FFR measurements. The sensitivity and specificity of the AutocathFFR will be calculated, as well as the AutocathFFR accuracy, positive predictive value and negative predictive value per lesion. Device success will be calculated as the ratio of completed versus initiated AutocathFFR index calculations. Usability of the AutocathFFR software will be evaluated using dedicated questionnaires to be completed by the user (cardiologists).

Conditions

Stable Angina, Unstable Angina, NSTEMI

Outcome Measures

Primary Outcomes (1)

• To assess the performance (sensitivity, specificity, accuracy) of the AutocathFFR measurements obtained from angiograms for the non-invasive determination of the presence of hemodynamically significant coronary lesions.

  The software device will be run on angiograms generated during cardiac catheterization and will be compared to the gold standard, invasive fractional flow reserve (FFR) measurements.

  2 months

Study Arms (1)

: adult subjects who underwent a clinically indicated invasive coronary angiography

adult subjects with stable angina, unstable angina or NSTEM1 who underwent a clinically indicated invasive coronary angiography and on whom invasive FFR has been measured in vessels with coronary lesions. Interventions: Other: Collecting invasive FFR measurements.

Other: Collecting invasive FFR measurements.

Interventions

Collecting invasive FFR measurements. OTHER

Invasive FFR measurements from the patient's hospital records will be collected.

Also known as: Data collection

: adult subjects who underwent a clinically indicated invasive coronary angiography

Eligibility Criteria

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

Study Population

Retrospective analysis of coronary angiograms of 100 consecutive patients who have undergone fractional flow reserve (FFR) testing within our institution

You may qualify if:

• patients who are \>18 years of age, undergone a coronary angiogram for a clinically indicated reason, and who underwent coronary hemodynamic testing with invasive FFR.

You may not qualify if:

• Invasive FFR not obtained

Sponsors & Collaborators

• University of California, San Diego: lead
• MedHub-AI: collaborator

Study Sites (1)

UC San Diego Health

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ehtisham Mahmud, MD

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Division Chief, Cardiovascular Medicine

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: August 22, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)