Physiological Patterns of Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03824600
• Lead Sponsor: Onze Lieve Vrouw Hospital

Brief Summary

Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

Detailed Description

A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.

Study Timeline

• Study Start: 2017-11-24
• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Stable coronary artery disease

Exclusion Criteria

• acute coronary syndromes
• previous coronary artery bypass grafting
• significant valvular disease
• severe obstructive pulmonary disease or asthma bronchial
• severe tortuosity or severe calcification

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)	Immediate post-procedure. No follow-up is schedule for this trial.	Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).

Trial Locations

Locations (2)

University of Brussels; 🇧🇪 Brussels, Belgium

OLV Aalst; 🇧🇪 Aalst, West Flanders, Belgium