Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04312802
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-20
First Post:
2020-03-16
Brief Title:
Cardiopulmonary Testing for Potential Pancreas Transplant Candidates
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
Measurement of Cardiopulmonary Exercise Capacity in Patients With Type 1 Diabetes Mellitus Approaching Simultaneous Kidney Pancreas Transplantation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients being assessed for Kidney Pancreas transplantation often have pre-existing co-morbid disease that contributes to structural cardiac and vascular disease There is no consensus on optimal pre-listing cardiac assessment to reliably minimize risk of peri-operative cardiac events Functional status using the cardio-pulmonary exercise test CPET has been used in cardiac and abdominal surgery including abdominal aortic aneurysm AAA repair and kidney transplantation but high risk patients with diabetes are often lacking from these studies This study will investigate the correlation between function measures using CPET and standard cardiac assessment and determine the variation in usual measures of anaerobic threshold and VO2 max in this population
Detailed Description:
20 participants will be recruited to a blinded observational study Patients referred for pancreas kidney transplantation assessment will be provided information about the study They will subsequently be approached at their initial assessment visit and informed consent will be taken
Participants will have standard clinical assessment which includes
1 Clinical history and examination
2 12 lead electrocardiogram ECG
3 Chest X-ray CXR
4 Myocardial perfusion imaging MPS
5 If MPS imaging is suggestive of stress induced ischaemia or severe left ventricular LV dysfunction the participant will undergo coronary angiography as part of standard assessment protocol
In addition study participants will undergo CPET testing This will take place within 1 week of the standard peri-operative cardiac assessment The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer Information about the study or participants individual results will not normally be disclosed to the participant or clinical team and so will not influence clinical management However if when the results are analysed the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant or until they are removed from the waiting list
At the end of the study the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events
Participants will have standard clinical assessment which includes
1 Clinical history and examination
2 12 lead electrocardiogram ECG
3 Chest X-ray CXR
4 Myocardial perfusion imaging MPS
5 If MPS imaging is suggestive of stress induced ischaemia or severe left ventricular LV dysfunction the participant will undergo coronary angiography as part of standard assessment protocol
In addition study participants will undergo CPET testing This will take place within 1 week of the standard peri-operative cardiac assessment The results of this investigation will be recorded against a unique identifier on a secure Oxford University Hospital computer Information about the study or participants individual results will not normally be disclosed to the participant or clinical team and so will not influence clinical management However if when the results are analysed the research team note a CPET result that suggests a clear and significant impairment of functional reserve such that the participant should not be listed this result will be disclosed to the individual and their medical team so that the information can be used in order to make the safest decision about transplant listing There will be no further clinical visits but participants will consent to collection of their clinical data until 3 months post-transplant or until they are removed from the waiting list
At the end of the study the results of CPET testing will be correlated to measures from standard cardiac investigations and to peri-operative cardiac events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None