Coronary Artery DiseaseNCT04001452
2nd International Survey on Interventional Strategies
An observational study of Coronary Artery Disease, run by Medical University of Graz.
Trial summary
The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be invited to join the survey via different online platforms and via social media.
Who may be able to join
- Interventional cardiologists
- Interventional cardiologists in training
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Emanuele Barbato, MD, PhD contact
About this study
The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Secondary outcomes (2)
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
Measured: One month
Accuracy of visually estimated lesion severity
Visually estimated diameter stenosis will be compared to quantitatively assessed diameter stenosis
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Gabor Toth-Gayor, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001452
- Sponsor's protocol ID
- ISIS 2
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25336468G 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.
PubMed 33971185
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2nd International Survey on Interventional Strategies
- ClinicalTrials.gov ID
- NCT04001452
- Acronym / sponsor ID
- ISIS 2
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be invited to join the survey via different online platforms and via social media.
Key inclusion criteria (2 listed)
- Interventional cardiologists
- Interventional cardiologists in training
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Need for using any additional diagnostic tool in different subgroups
Time frame: One month
Accuracy of visually estimated lesion severity
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Background: PubMed 25336468Toth 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.
- Derived from this study: PubMed 33971185G 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Barbato, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabor G Toth, MD, PhD (0043 316 385 12544, gabor.g.toth@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for using any additional diagnostic tool (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.