Coronary Artery DiseaseNCT04907786
CCTA-guided Ultraselective Invasive Coronary Angiography
An observational study of Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Coronary artery disease (CAD) is the leading cause of death in adults in the United States.[1] In the latest guidelines of the European Society of Cardiology anatomical non-invasive imaging by coronary computed tomography angiography (CCTA) plays an important role in the diagnosis of the presence of CAD in patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 31 Dec 2022
- How long will I take part?
- 90 Days
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: The prospected study population is 250 patients. This study population allows for enough statistical power to answer all endpoints as described above. Due to the fact that only a few patients with abnormalities on the CCTA limited to the RCA were analyzed in the retrospective study, we defined that at least 15% of the patient population must consist of patients with an abnormal RCA on CCTA. In order to reach this distribution, inclusion of patients with abnormalities in the LCA on CCTA may be halted in favor of patients with abnormalities in the RCA.
Who may be able to join
- Patients undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery within 90 days.
Who cannot join
- Refusal of informed consent
- Abnormalities in both coronary arteries on CCTA
- Prior PCI
- Prior coronary artery bypass grafting (CABG)
- Major allergy to iodinated contrast agent
- Inability to provide informed consent, and/or known pregnancy.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Lokien X van Nunen, MD PhD, +31402397004, lokien.v.nunen@catharinaziekenhuis.nl
Lokien X van Nunen, MD PhD
About this study
Official title: Coronary Computed Tomography Angiography Guidance in Invasive Coronary Angiography; a Prospective Registry Study
Coronary artery disease (CAD) is the leading cause of death in adults in the United States.[1] In the latest guidelines of the European Society of Cardiology anatomical non-invasive imaging by coronary computed tomography angiography (CCTA) plays an important role in the diagnosis of the presence of CAD in patients without a history of CAD and a low to intermediate likelihood.[2] CCTA provides high accuracy for the detection of coronary artery disease by visualizing the coronary artery lumen using an intravenous contrast agent.[3] However to determine the hemodynamical significance of CCTA-identified stenosis, invasive coronary angiography (ICA) with or without functional testing is still required. [4] During the ICA as per protocol the complete coronary artery system is visualized again. In patients with abnormalities on CCTA in only one coronary artery, i.e. only the left coronary artery (LCA) or the right coronary artery (RCA), the ICA procedure might be simplified by 'ultraselectively' visualizing only the coronary artery of interest and refraining from angiographic visualization of the contralateral coronary artery without abnormalities on CCTA (with an excellent negative predictive value of 95-99%).[5-7] Such an ultraselective strategy might reduce procedure time, usage of catheters, complication risk and the amount of contrast agent and radiation exposure.
A recent retrospective study in three hospitals in the Netherlands showed CCTA to be extremely accurate in predicting a normal contralateral coronary artery in patients with coronary artery disease limited to the left or right coronary artery. Therefore, a CCTA-guided ultraselective ICA approach would have been safe and feasible and would have led to a considerable decrease in procedure time and radiation exposure.
Read more
However, the analysis was hampered by the retrospective design. The potential benefits in salvage of procedure time and radiation exposure might be overestimated and it turned out to be impossible to measure the effects on contrast use, catheter use and procedure costs. Moreover, in the retrospective study only a small portion of the study population had abnormalities in the right coronary artery, thereby questioning the results of this study to safely be extrapolated to this category of patients with abnormalities in the RCA.
This dual-center prospective registry study is designed to answer these remaining questions and to further investigate the potential benefit of an ultraselective ICA approach.
Read the detailed description
Study design \& patient population
The study is a dual-center prospective registry in two hospitals in the Netherlands. All patients eligible for participation in this registry are aged 18-80 years old and undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery.
Patients will be asked for written informed consent to register their clinical data in an anonymized database. The period between CCTA and ICA may not exceed 90 days, in order to prevent possible aggravation of coronary artery disease between both examinations.
Clinical characteristics (age, gender, risk factors, relevant medical history) and CCTA data will be included in the database. All procedural characteristics and findings of the invasive coronary angiography procedure will be logged, including access site, procedural planning (which coronary artery to be visualized first), procedure duration, amount and type of catheters used, amount of radiation exposure and contrast volume, procedural findings, type of coronary intervention (if applicable), and complications. Procedure duration is defined as the time needed for the diagnostic part of the ICA procedure, possible further functional invasive testing and/or percutaneous coronary intervention is excluded. ICA data will be compared to the CCTA data on a per-patient level. No further follow-up is planned after the invasive coronary angiography with regards to participating in this registry.
Informed consent
If patients provide informed consent, the data will be registered in an anonymized database. Patients can withdraw from this study at any time at their own request, or they may be withdrawn at the discretion of the investigator for behavioral, or administrative reasons. The reason(s) for discontinuation will be documented and may include: the subject voluntarily withdraws from registry.
Since the patients will not be subjected to any additional procedures, rules or behavior and the data will be anonymized, we believe this research design does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO).
Database and data protection
Data will be stored anonymized in an online database and will only be accessible to the involved researchers. Personal data will comply to the Dutch Personal Data Protection Act. Site investigators will only be able to add patients from their own site, and will only be able to see patients from their own site. Data generated will be encoded and a separate patient identification log will be created for each site, and stored at each site separately. The key to the code will be available to specific site investigators only. There will be at least one study coordinator that has access to all records of all sites. In the future data from other centers could be included into the database using this similar pattern to ensure data protection.
- Conditions
- Coronary Artery Disease
- Keywords
- Invasive coronary angiography, Coronary computed tomographic angiography, Radiation exposure, Contrast volume, Procedure costs
- 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 |
|---|---|---|
| Study population | All patients eligible for participation in this registry are aged 18-80 years old and undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery. Patients will be asked for written informed consent to register their clinical data in an anonymized database. The period between CCTA and ICA may not exceed 90 days, in order to prevent possible aggravation of coronary artery disease between both examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CCTA
The accuracy of CCTA to defer invasive angiography of the contralateral coronary artery, in patients with abnormalities on CCTA limited to either the left or right coronary artery and a normal or minimal abnormal contralateral artery (defined as CAD-RADS 0-1; 0-24% stenosis)
Measured: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Secondary outcomes (4)
Reduction in procedure time
The time to visualize the contralateral coronary artery without abnormalities on CCTA will be considered as superfluous and is therefore a potential benefit of an ultraselective ICA.
Measured: At the end of the invasive coronary angiography procedure, an average of 25 minutes.
Reduction in radiation
The radiation used to to visualize the contralateral coronary artery without abnormalities on CCTA will will be considered as superfluous and is therefore a potential benefit of an ultraselective ICA.
Measured: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Reduction in contrast volume
The contrast volume used to to visualize the contralateral coronary artery without abnormalities on CCTA will be considered as superfluous and is therefore a potential benefit of an ultraselective ICA.
Measured: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Reduction in catheter usage
The amount of catheter used to visualize the contralateral coronary artery without abnormalities on CCTA will be considered as superfluous and is therefore a potential benefit of an ultraselective ICA.
Measured: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- The Elisabeth-TweeSteden Hospital
- Responsible party
- Principal investigator, Lokien van Nunen, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907786
- Sponsor's protocol ID
- Ultraselective Registry
- Status last verified
- Jul 2021
- First submitted
- 21 May 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
PubMed 29386200Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Knuuti J, Ballo H, Juarez-Orozco LE, Saraste A, Kolh P, Rutjes AWS, Juni P, Windecker S, Bax JJ, Wijns W. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018 Sep 14;39(35):3322-3330. doi: 10.1093/eurheartj/ehy267.
PubMed 29850808Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.
PubMed 20579537Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
PubMed 19007693Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
PubMed 19095130Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
PubMed 19038879
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography Angiography Guidance in Invasive Coronary Angiography; a Prospective Registry Study
- ClinicalTrials.gov ID
- NCT04907786
- Acronym / sponsor ID
- Ultraselective Registry
- Conditions
- Coronary Artery Disease
- Keywords
- Invasive coronary angiography, Coronary computed tomographic angiography, Radiation exposure, Contrast volume, Procedure costs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- The Elisabeth-TweeSteden Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Jun 2021 (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.
Coronary artery disease (CAD) is the leading cause of death in adults in the United States.[1] In the latest guidelines of the European Society of Cardiology anatomical non-invasive imaging by coronary computed tomography angiography (CCTA) plays an important role in the diagnosis of the presence of CAD in patients without a history of CAD and a low to intermediate likelihood.[2] CCTA provides high accuracy for the detection of coronary artery disease by visualizing the coronary artery lumen using an intravenous contrast agent.[3] However to determine the hemodynamical significance of CCTA-identified stenosis, invasive coronary angiography (ICA) with or without functional testing is still required. [4] During the ICA as per protocol the complete coronary artery system is visualized again. In patients with abnormalities on CCTA in only one coronary artery, i.e. only the left coronary artery (LCA) or the right coronary artery (RCA), the ICA procedure might be simplified by 'ultraselectively' visualizing only the coronary artery of interest and refraining from angiographic visualization of the contralateral coronary artery without abnormalities on CCTA (with an excellent negative predictive value of 95-99%).[5-7] Such an ultraselective strategy might reduce procedure time, usage of catheters, complication risk and the amount of contrast agent and radiation exposure.
A recent retrospective study in three hospitals in the Netherlands showed CCTA to be extremely accurate in predicting a normal contralateral coronary artery in patients with coronary artery disease limited to the left or right coronary artery. Therefore, a CCTA-guided ultraselective ICA approach would have been safe and feasible and would have led to a considerable decrease in procedure time and radiation exposure.
However, the analysis was hampered by the retrospective design. The potential benefits in salvage of procedure time and radiation exposure might be overestimated and it turned out to be impossible to measure the effects on contrast use, catheter use and procedure costs. Moreover, in the retrospective study only a small portion of the study population had abnormalities in the right coronary artery, thereby questioning the results of this study to safely be extrapolated to this category of patients with abnormalities in the RCA.
This dual-center prospective registry study is designed to answer these remaining questions and to further investigate the potential benefit of an ultraselective ICA approach.
Detailed description
Study design \& patient population
The study is a dual-center prospective registry in two hospitals in the Netherlands. All patients eligible for participation in this registry are aged 18-80 years old and undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery.
Patients will be asked for written informed consent to register their clinical data in an anonymized database. The period between CCTA and ICA may not exceed 90 days, in order to prevent possible aggravation of coronary artery disease between both examinations.
Clinical characteristics (age, gender, risk factors, relevant medical history) and CCTA data will be included in the database. All procedural characteristics and findings of the invasive coronary angiography procedure will be logged, including access site, procedural planning (which coronary artery to be visualized first), procedure duration, amount and type of catheters used, amount of radiation exposure and contrast volume, procedural findings, type of coronary intervention (if applicable), and complications. Procedure duration is defined as the time needed for the diagnostic part of the ICA procedure, possible further functional invasive testing and/or percutaneous coronary intervention is excluded. ICA data will be compared to the CCTA data on a per-patient level. No further follow-up is planned after the invasive coronary angiography with regards to participating in this registry.
Informed consent
If patients provide informed consent, the data will be registered in an anonymized database. Patients can withdraw from this study at any time at their own request, or they may be withdrawn at the discretion of the investigator for behavioral, or administrative reasons. The reason(s) for discontinuation will be documented and may include: the subject voluntarily withdraws from registry.
Since the patients will not be subjected to any additional procedures, rules or behavior and the data will be anonymized, we believe this research design does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO).
Database and data protection
Data will be stored anonymized in an online database and will only be accessible to the involved researchers. Personal data will comply to the Dutch Personal Data Protection Act. Site investigators will only be able to add patients from their own site, and will only be able to see patients from their own site. Data generated will be encoded and a separate patient identification log will be created for each site, and stored at each site separately. The key to the code will be available to specific site investigators only. There will be at least one study coordinator that has access to all records of all sites. In the future data from other centers could be included into the database using this similar pattern to ensure data protection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –All patients eligible for participation in this registry are aged 18-80 years old and undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery. Patients will be asked for written informed consent to register their clinical data in an anonymized database. The period between CCTA and ICA may not exceed 90 days, in order to prevent possible aggravation of coronary artery disease between both examinations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The prospected study population is 250 patients. This study population allows for enough statistical power to answer all endpoints as described above. Due to the fact that only a few patients with abnormalities on the CCTA limited to the RCA were analyzed in the retrospective study, we defined that at least 15% of the patient population must consist of patients with an abnormal RCA on CCTA. In order to reach this distribution, inclusion of patients with abnormalities in the LCA on CCTA may be halted in favor of patients with abnormalities in the RCA.
Key inclusion criteria (1 listed)
- Patients undergoing invasive coronary angiography because of abnormalities found on CCTA in either the left or right coronary artery and no or minimal stenosis (CAD-RADS 0-1; 0-24% stenosis) in the contralateral coronary artery within 90 days.
Key exclusion criteria (6 listed)
- Refusal of informed consent
- Abnormalities in both coronary arteries on CCTA
- Prior PCI
- Prior coronary artery bypass grafting (CABG)
- Major allergy to iodinated contrast agent
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
Accuracy of CCTA
Time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes
The accuracy of CCTA to defer invasive angiography of the contralateral coronary artery, in patients with abnormalities on CCTA limited to either the left or right coronary artery and a normal or minimal abnormal contralateral artery (defined as CAD-RADS 0-1; 0-24% stenosis)
4 secondary outcomes
Reduction in procedure time
Time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes.
Reduction in radiation
Time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Reduction in contrast volume
Time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Reduction in catheter usage
Time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 29386200Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Background: PubMed 31504439Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
- Background: PubMed 29850808Knuuti J, Ballo H, Juarez-Orozco LE, Saraste A, Kolh P, Rutjes AWS, Juni P, Windecker S, Bax JJ, Wijns W. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J. 2018 Sep 14;39(35):3322-3330. doi: 10.1093/eurheartj/ehy267.
- Background: PubMed 20579537Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.
- Background: PubMed 19007693Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
- Background: PubMed 19095130Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.
- Background: PubMed 19038879Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 1 inclusion and 6 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lokien X van Nunen, MD PHD (+31 40 2397004, lokien.v.nunen@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of CCTA (time frame: At the end of the invasive coronary angiography procedure, an average of 25 minutes). 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 NCT04907786, which also lists 7 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 3 Aug 2021.