CCTA-guided Ultraselective Invasive Coronary Angiography
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ClinicalTrials.gov Identifier: NCT04907786 |
Recruitment Status : Unknown
Verified July 2021 by Lokien van Nunen, Catharina Ziekenhuis Eindhoven.
Recruitment status was: Recruiting
First Posted : June 1, 2021
Last Update Posted : August 3, 2021
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Tracking Information | |||||
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First Submitted Date | May 21, 2021 | ||||
First Posted Date | June 1, 2021 | ||||
Last Update Posted Date | August 3, 2021 | ||||
Actual Study Start Date | July 1, 2021 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | CCTA-guided Ultraselective Invasive Coronary Angiography | ||||
Official Title | Coronary Computed Tomography Angiography Guidance in Invasive Coronary Angiography; a Prospective Registry Study | ||||
Brief 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 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. |
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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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | 90 Days | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
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. | ||||
Condition | Coronary Artery Disease | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | 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.
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
250 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04907786 | ||||
Other Study ID Numbers | Ultraselective Registry | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | Lokien van Nunen, Catharina Ziekenhuis Eindhoven | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Catharina Ziekenhuis Eindhoven | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | The Elisabeth-TweeSteden Hospital | ||||
Investigators | Not Provided | ||||
PRS Account | Catharina Ziekenhuis Eindhoven | ||||
Verification Date | July 2021 |