NCT03420131

Brief Summary

A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 27, 2018

Last Update Submit

January 27, 2018

Conditions

Fractional Flow Reserve, MyocardialCoronary Artery Disease

Keywords

instantaneous Flow RatioQuantitative Flow RatioFractional Flow Reserve

Outcome Measures

Primary Outcomes (2)

  • Diagnostic performance of QFR in comparison to iFR

    reported as sensitivity, specificity, positive and negative likelihood ratio of QFR according to iFR

    1 hour

  • QFR- iFR diagnostic grey zone calculation.

    QFR limits for achieving 95% sensitivity and specificity in comparison to iFR

    1 hour

Secondary Outcomes (7)

  • Diagnostic performance of QFR in comparison to FFR

    1 hour

  • QFR- FFR diagnostic grey zone calculation.

    1 hour

  • Diagnostic performance of iFR in comparison to FFR

    1 hour

  • iFR- FFR diagnostic grey zone calculation.

    1 hour

  • effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.

    1 hour

  • +2 more secondary outcomes

Other Outcomes (1)

  • Cost analysis

    1 hour

Study Arms (1)

FFR-iFR-QFR group

Diagnostic Test: QFR and iFR

Interventions

QFR and iFRDIAGNOSTIC_TEST

iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland

FFR-iFR-QFR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that undergo angiography because of symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing or abnormal noninvasive testing) and in whom hemodynamic evaluation of an intermediate stenosis is indicated should be screened and considered for participation in the trial The trial design is set up to be representative for the patient population that under current guidelines should be evaluated with FFR. Therefore the exclusion criteria are limited to the contraindications for adenosine and previous CABG which would not allow accurate evaluation by FFR and QFR respectively.

You may qualify if:

  • Age \> 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
  • Patients witch semi recent (\>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
  • Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
  • Eligible for coronary angiography and/or percutaneous coronary intervention
  • Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.

You may not qualify if:

  • Contraindication to adenosine administration
  • Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contilia heart and vascular center

Essen, North Rhine-Westphalia, 45138, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Christoph j Jensen, MD

    contilia heart and vascular center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Jensen, MD, PHD

CONTACT

0049-201-897-86222c.jensen@contilia.de

Pieter Ghijselinck, MD

CONTACT

0049-201-897-86273p.ghijselinck@contilia.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christoph Jensen, MD, Associate Professor of medicine

Study Record Dates

First Submitted

January 27, 2018

First Posted

February 5, 2018

Study Start

July 18, 2017

Primary Completion

July 28, 2018

Study Completion

October 1, 2018

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

DE(1)