Physiological Patterns of Coronary Artery Disease

NCT ID: NCT03824600

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-24

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeroen Sonck

Co-Director Catheterization Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard De Bruyne, MD, PhD

Role: STUDY_CHAIR

OLV-Aalst

Locations

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OLV Aalst

Aalst, West Flanders, Belgium

Site Status

University of Brussels

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Argacha JF, Decamp J, Vandeloo B, Babin D, Lochy S, Van den Bussche K, de Hemptinne Q, Xaplanteris P, Magne J, Segers P, Cosyns B. Guiding Myocardial Revascularization by Algorithmic Interpretation of FFR Pullback Curves: A Proof of Concept Study. Front Cardiovasc Med. 2021 Mar 11;8:623841. doi: 10.3389/fcvm.2021.623841. eCollection 2021.

Reference Type DERIVED
PMID: 33778020 (View on PubMed)

Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072.

Reference Type DERIVED
PMID: 31582137 (View on PubMed)

Other Identifiers

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CRI-0002

Identifier Type: -

Identifier Source: org_study_id

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