NCT04001452

Brief Summary

The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 8, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

June 8, 2019

Last Update Submit

June 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Need for using any additional diagnostic tool

    It will be assessed, how often participants express their desire to use one or other additional diagnostic tool to make a decision about lesion significance

    One month

Secondary Outcomes (2)

  • Need for using any additional diagnostic tool in different subgroups

    One month

  • Accuracy of visually estimated lesion severity

    One month

Study Arms (5)

Level of experience in interventional cardiology

Total cohort will be grouped according to experience in interventional cardiology, as defined by a single choice questionnaire: Yearly personal PCI volume Less than 75 / Between 75 and 150 / Between 151 and 250 / More than 250

Level of experience with intravascular ultrasound

Total cohort will be grouped according to experience with intravascular ultrasound, as defined by a single choice questionnaire: General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years Yearly: None / Less than 15 / Between 15 and 50 / More than 50

Level of experience with optical coherence tomography

Total cohort will be grouped according to experience with optical coherence tomography, as defined by a single choice questionnaire: General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years Yearly: None / Less than 15 / Between 15 and 50 / More than 50

Level of experience with fractional flow reserve

Total cohort will be grouped according to experience with fractional flow reserve, as defined by a single choice questionnaire: General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years Yearly: None / Less than 50 / Between 50 and 150 / Between 151 and 250 / More than 250

Level of experience with non-hyperaemic pressure ratios

Total cohort will be grouped according to experience with non-hyperaemic pressure ratios, as defined by a single choice questionnaire: General: No experience / Less than 1 year / Between 1 and 3 years / Between 3 and 5 years / More than 5 years Yearly: None / Less than 50 / Between 50 and 150 / Between 151 and 250 / More than 250

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be invited to join the survey via different online platforms and via social media.

You may qualify if:

  • Interventional cardiologists
  • Interventional cardiologists in training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Toth GG, Toth B, Johnson NP, De Vroey F, Di Serafino L, Pyxaras S, Rusinaru D, Di Gioia G, Pellicano M, Barbato E, Van Mieghem C, Heyndrickx GR, De Bruyne B, Wijns W. Revascularization decisions in patients with stable angina and intermediate lesions: results of the international survey on interventional strategy. Circ Cardiovasc Interv. 2014 Dec;7(6):751-9. doi: 10.1161/CIRCINTERVENTIONS.114.001608. Epub 2014 Oct 21.

    PMID: 25336468BACKGROUND
  • G Toth G, Johnson NP, Wijns W, Toth B, Achim A, Fournier S, Barbato E. Revascularization decisions in patients with chronic coronary syndromes: Results of the second International Survey on Interventional Strategy (ISIS-2). Int J Cardiol. 2021 Aug 1;336:38-44. doi: 10.1016/j.ijcard.2021.05.005. Epub 2021 May 7.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Emanuele Barbato, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2019

First Posted

June 28, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

June 28, 2019

Record last verified: 2019-06