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Physiological Patterns of Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03824600
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jeroen Sonck, Onze Lieve Vrouw Hospital

Study Description
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Brief Summary:
Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: Fractional Flow Reserve Motorized Pullback

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Physiological Patterns of Coronary Artery Disease
Actual Study Start Date : November 24, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : September 30, 2019

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Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Fractional Flow Reserve Motorized Pullback
    A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.

Outcome Measures
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Primary Outcome Measures :
  1. Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined) [ Time Frame: 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).


Other Outcome Measures:
  1. Classification of the physiological patterns of coronary artery disease using a quantitative metric [ Time Frame: Immediate post-procedure. No follow-up is schedule for this trial. ]
    Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients undergoing clinically indicated coronary angiography and fractional flow reserve evaluation for intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824600


Locations
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Belgium
OLV Aalst
Aalst, West Flanders, Belgium, 9300
University of Brussels
Brussels, Belgium, 1090
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
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Study Chair: Bernard De Bruyne, MD, PhD OLV-Aalst
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jeroen Sonck, Co-Director Catheterization Laboratory, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT03824600    
Other Study ID Numbers: CRI-0002
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases