Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty (QIMERA-I)
Primary Purpose
Coronary Occlusion
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Quantitative Flow Ratio (QFR) measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Occlusion focused on measuring Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
- Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.
Exclusion Criteria:
- Severe stenosis of the left main coronary artery.
- Patients admitted with ST-elevation myocardial infarction.
- Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
- Unability to identify the culprit lesion in NSTE-ACS patients.
Sites / Locations
- Complejo Hospitalario Universitario, Santiago de CompostelaRecruiting
- Hospital de LugoRecruiting
- Hospital Clínico San CarlosRecruiting
- Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
- Hospital Clínico Universitario de ValladolidRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QFR Intervention
Arm Description
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.
Outcomes
Primary Outcome Measures
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
Secondary Outcome Measures
Sensitivity
Specificity
Summary of the receiver-operator characteristics curve (sROC)
Negative predictive value
Positive predictive value
Positive likelihood ratio
Negative likelihood ratio
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.
Full Information
NCT ID
NCT04200469
First Posted
December 13, 2019
Last Updated
September 23, 2021
Sponsor
Hospital Clínico Universitario de Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT04200469
Brief Title
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Acronym
QIMERA-I
Official Title
Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clínico Universitario de Valladolid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective intervention study to assess the accuracy of the predicted QFR-derived virtual angioplasty compared to hyperaemic and non-hyperaemic pressure-wire derived indexes after PCI, as well as with QFR post-PCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Occlusion
Keywords
Quantitative Flow Ratio, QFR, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QFR Intervention
Arm Type
Experimental
Arm Description
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis between 50 and 90% and PCI indication with paired assessment of QFR, dFR, RFR and FFR, before and after PCI once informed consent is provided.
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative Flow Ratio (QFR) measurement
Intervention Description
Quantitative flow ratio (QFR) is a novel approach enabling rapid computation of FFR pullbacks from three-dimensional quantitative coronary angiography (3D-QCA) without using a pressure wire.
Primary Outcome Measure Information:
Title
Numerical agreement between predicted post PCI QFR (residual QFR) and post PCI dPR RFR-FFR, as well as direct QFR post-PCI mesurement.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Sensitivity
Time Frame
1 hour
Title
Specificity
Time Frame
1 hour
Title
Summary of the receiver-operator characteristics curve (sROC)
Time Frame
1 hour
Title
Negative predictive value
Time Frame
1 hour
Title
Positive predictive value
Time Frame
1 hour
Title
Positive likelihood ratio
Time Frame
1 hour
Title
Negative likelihood ratio
Time Frame
1 hour
Title
Identification of independent predictors for increased predicted postPCI QFR (residual QFR) and post PCI dPR-RFR-FFR.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients submitted to a coronary angiogram with at least one non-left main stable coronary stenosis with PCI indication.
Exclusion Criteria:
Severe stenosis of the left main coronary artery.
Patients admitted with ST-elevation myocardial infarction.
Culprit lesions in Non-ST-Elevation Acute Coronary Syndromes (NSTEACS) patients.
Unability to identify the culprit lesion in NSTE-ACS patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Baladron, PhD
Phone
+34983420000
Email
icicor@icicor.es
Facility Information:
Facility Name
Complejo Hospitalario Universitario, Santiago de Compostela
City
Santiago De Compostela
State/Province
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José R Rumoroso, MD
First Name & Middle Initial & Last Name & Degree
Mario Sadaba
Facility Name
Hospital de Lugo
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymundo Ocaranza-Sanchez, PhD, MD
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Escaned, PhD, MD
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Pinar, PhD
First Name & Middle Initial & Last Name & Degree
Ramon López-Palop, PhD, MD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Baladron, Dr.
Phone
983420000
First Name & Middle Initial & Last Name & Degree
Alfredo Redondo-Diéguez, MD
First Name & Middle Initial & Last Name & Degree
Ignacio J Amat-Santos, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Validation Of Quantitative Flow Ratio (QFR) - Derived Virtual Angioplasty
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