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2nd International Survey on Interventional Strategies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001452
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Gabor Toth-Gayor, Medical University of Graz

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 2nd International Survey on Interventional Strategies
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Accuracy of visually estimated lesion severity [ Time Frame: One month ]
    Visually estimated diameter stenosis will be compared to quantitatively assessed diameter stenosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be invited to join the survey via different online platforms and via social media.
Criteria

Inclusion criteria

  • Interventional cardiologists
  • Interventional cardiologists in training

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001452


Contacts
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Contact: Gabor G Toth, MD, PhD 0043 316 385 12544 gabor.g.toth@medunigraz.at
Contact: Emanuele Barbato, MD, PhD emanuele.barbato@unina.it

Sponsors and Collaborators
Medical University of Graz
Abbott

Publications:
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Responsible Party: Gabor Toth-Gayor, Principal Investigator, Medical University of Graz
ClinicalTrials.gov Identifier: NCT04001452    
Other Study ID Numbers: ISIS 2
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases