Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03248674
Status:
TERMINATED
Last Update Posted:
2022-01-06
First Post:
2017-08-10
Brief Title:
Diagnostic Performance of Coronary CT Angiography With CT FFR in Kidney Transplantation Candidates
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Diagnostic Performance of Coronary Computed Tomography Angiography With Computed Tomography Fractional Flow Reserve in Kidney Transplantation Candidates
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with recruitment in this patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with chronic kidney disease CKD before kidney transplantation require that obstructive coronary artery disease CAD is excluded as cardiovascular complications are the leading cause of mortality in kidney transplant patients However in this patient population the optimal method for the detection of obstructive CAD has not been identified Noninvasive stress tests such as Dobutamine stress echocardiography or nuclear perfusion study have low diagnostic accuracy CT fractional flow reserve measurement CT FFR is a novel non-invasive FDA approved imaging test to identify obstructive CAD The goal of this project is to evaluate the diagnostic accuracy of CT FFR in the detection of obstructive coronary artery disease in patients with chronic kidney disease before kidney transplantation
Detailed Description:
Transplantation is the therapy of choice for most patients with stage 5 chronic kidney disease CKD and end stage renal disease ESRD Kidney transplantation improves quality of life and overall survival rates Cardiovascular disease is the most common complication and leading cause of death in the transplant population In order to assess the risk of cardiac events perioperatively and after kidney transplantation the majority of kidney transplantation candidates undergo cardiac evaluation including non-invasive cardiac stress imaging or invasive coronary angiography before transplantation Invasive coronary angiography is associated with small but definite risk of bleeding or myocardial infarction making non-invasive cardiac stress imaging such as dobutamine stress echocardiography DSE or nuclear myocardial perfusion scintigraphy MPS the preferred method However non-invasive cardiac stress imaging in patients with stage 5 CKD and ESRD demonstrates only moderate accuracy DSE and MPS showed only sensitivities ranging from 044 to 089 and from 029 to 092 respectively for identifying one or more severe coronary artery stenosis defined as coronary diameter stenosis of more than 70 Due to the moderate accuracy several transplant centers including Stanford still continue to rely on invasive coronary angiography for their populations instead of non-invasive cardiac testing Thus improved non-invasive cardiac testing with higher sensitivities and specificity are highly desirable in this patient population
A promising alternative is the use of coronary CT angiography cCTA in combination with CT based fractional flow reserve CT-FFR Non-invasive cCTA alone has recently been evaluated in kidney transplantation candidates It demonstrated high sensitivity 093 but limited specificity 063 in the detection of obstructive coronary artery disease most likely related to the high prevalence of coronary artery calcifications in patients with CKD and ESRD The specificity of coronary CTA can be improved by a new image analysis techniques which allow the calculation of the hemodynamic significance - expressed as the relative pressure drop across a lesion similar - based on computational fluid dynamics derived from the conventional coronary CTA 6 In various study populations the combination of coronary CT angiography and CT FFR showed excellent correlation with invasive FFR derived from invasive coronary angiography which is the current gold standard The implementation of CT- FFR has shown an improvement of the specificity of coronary CTA even in the presence of coronary artery calcifications However no study so far assessed the diagnostic accuracy of coronary angiography with CT-FFR in candidates for kidney transplantation
Goal The objective of this project is to evaluate and establish a new non-invasive cardiac test in the detection of coronary artery disease for candidates before kidney transplantation
Specific Aims We want to confirm the promising results of CT FFR in this specific patient population and want to establish an alternative non-invasive cardiac test
Study Design This study is designed as a prospective observational cohort study with a study population of 50 -100 patients All patients who are included in this study will undergo coronary CT angiography with CT-FFR research part and a clinically indicated invasive coronary angiography with invasive FFR standard of care Coronary angiography and invasive FFR will act as the reference standard
A promising alternative is the use of coronary CT angiography cCTA in combination with CT based fractional flow reserve CT-FFR Non-invasive cCTA alone has recently been evaluated in kidney transplantation candidates It demonstrated high sensitivity 093 but limited specificity 063 in the detection of obstructive coronary artery disease most likely related to the high prevalence of coronary artery calcifications in patients with CKD and ESRD The specificity of coronary CTA can be improved by a new image analysis techniques which allow the calculation of the hemodynamic significance - expressed as the relative pressure drop across a lesion similar - based on computational fluid dynamics derived from the conventional coronary CTA 6 In various study populations the combination of coronary CT angiography and CT FFR showed excellent correlation with invasive FFR derived from invasive coronary angiography which is the current gold standard The implementation of CT- FFR has shown an improvement of the specificity of coronary CTA even in the presence of coronary artery calcifications However no study so far assessed the diagnostic accuracy of coronary angiography with CT-FFR in candidates for kidney transplantation
Goal The objective of this project is to evaluate and establish a new non-invasive cardiac test in the detection of coronary artery disease for candidates before kidney transplantation
Specific Aims We want to confirm the promising results of CT FFR in this specific patient population and want to establish an alternative non-invasive cardiac test
Study Design This study is designed as a prospective observational cohort study with a study population of 50 -100 patients All patients who are included in this study will undergo coronary CT angiography with CT-FFR research part and a clinically indicated invasive coronary angiography with invasive FFR standard of care Coronary angiography and invasive FFR will act as the reference standard
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None