2nd International Survey on Interventional Strategies

Coronary Artery Disease Clinical Trial

Official title:

2nd International Survey on Interventional Strategies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04001452
• Other study ID #: ISIS 2
• Status: Not yet recruiting
• Start date: July 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2019
• Source: Medical University of Graz
• Contact: Gabor G Toth, MD, PhD
• Phone: 0043 316 385 12544
• Email: gabor.g.toth[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

• Interventional cardiologists

• Interventional cardiologists in training

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Abbott

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for using any additional diagnostic tool in different subgroups	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
Secondary	Accuracy of visually estimated lesion severity	Visually estimated diameter stenosis will be compared to quantitatively assessed diameter stenosis	One month