2nd International Survey on Interventional Strategies

June 26, 2019 updated by: Gabor Toth-Gayor, Medical University of Graz
The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

Study Overview

Status

Unknown

Conditions

Detailed Description

2nd International Survey on Interventional Strategies is a web-based platform.

The survey contains specific questions and dedicated case presentations on two major topics.

The first part queries the characteristics of the participants, including overall experience in interventional cardiology, annual volume of percutaneous coronary intervention (PCI), and duration of experience with quantitative coronary angiography (QCA), intravascular ultrasound (IVUS),optical coherence tomography (OCT), fractional flow reserve (FFR) and non-hyperaemic pressure ratios (NHPR). The survey uses here predefined categories and single-choice questions.

The second part investigates personal strategies for evaluating angiographically intermediate stenoses in the catheterization laboratory. Here, participants are asked to evaluate 5 complete coronary angiograms. All cases are characterised as stable angina without relevant changes on resting ECG. No information about non-invasive testing is known or provided.

Here participants are asked to (1) localise all relevant stenoses by indicating the involved segment; (2) define percent diameter stenosis (%DS) by visual estimate; and (3) determine the significance of the stenosis of interest. In cases of angiographic uncertainty, the preferred diagnostic tool is asked to be selected from the arsenal available in the catheterisation laboratory, namely QCA, IVUS, OCT, FFR or NHPR. Participants are asked to make their decisions assuming ideal world conditions, without considering any financial restrictions or local regulations, but only after the best clinical practice achievable in this virtual catheterisation laboratory.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion criteria

  • Interventional cardiologists
  • Interventional cardiologists in training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for using any additional diagnostic tool
Time Frame: One month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for using any additional diagnostic tool in different subgroups
Time Frame: One month
It will be assessed, how often the different subgroups of participants (i.e. by age, by interventional experience, by experience with different tools) express their desire to use one or other additional diagnostic tool to make a decision about lesion significance
One month
Accuracy of visually estimated lesion severity
Time Frame: One month
Visually estimated diameter stenosis will be compared to quantitatively assessed diameter stenosis
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

January 31, 2020

Study Registration Dates

First Submitted

June 8, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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