Clinical trial NCT04001452: 2nd International Survey on Interventional Strategies
Official title: 2nd International Survey on Interventional Strategies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2019-06-28
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be invited to join the survey via different online platforms and via social media.

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

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.

Eligibility criteria: Inclusion criteria

* Interventional cardiologists
* Interventional cardiologists in training

Primary outcomes:
measure: Need for using any additional diagnostic tool
timeFrame: One month
Secondary outcomes:
measure: Need for using any additional diagnostic tool in different subgroups
timeFrame: One month
measure: Accuracy of visually estimated lesion severity
timeFrame: One month
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.