Cardiopulmonary Testing for Potential Pancreas Transplant Candidates
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Risk Factor
- Diabetes Mellitus - Type 1
- Pancreas Transplant; Complications
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 w...
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: Clinical history and examination 12 lead electrocardiogram (ECG) Chest X-ray (CXR) Myocardial perfusion imaging (MPS) 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.
Tracking Information
- NCT #
- NCT04312802
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Edward Sharples, MBBS PhD Oxford University Hospitals NHS Trust