Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation
AMI-SPK
1 other identifier
observational
50
1 country
1
Brief Summary
Diabetic cardiomyopathy( DCM) is a major complication of diabetes and is a common cardiovascular complication independent of coronary artery disease and hypertension．Trial to assess of myocardial injury in recipients of simultaneous pancreas and kidney transplantation by nuclear magnetic T２ mapping technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedApril 5, 2019
April 1, 2019
1 year
April 4, 2019
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of myocardial injury
Assessment of myocardial injury between two groups
1year
Study Arms (2)
SPKT
patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation
RT
patients with end-stage diabetic nephropathy got single kidney transplantation
Interventions
T2 value before transplant，3 month and 6month after transplant
Eligibility Criteria
A total of 25 patients with SPK who met the inclusion criteria and 25 patients with simple kidney transplantation for diabetic end-stage nephropathy were included by matching the onset time, gender, age, BMI and blood pressure of diabetes
You may qualify if:
- patients with type 2 diabetes were treated with SPK; 2.No definite history of cardiovascular diseases (such as congenital heart disease, coronary heart disease, cardiomyopathy or valvular heart disease, etc.); 3. Preoperative hemodialysis 4. No history of heart failure
You may not qualify if:
- Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin First central hospital
Tianjin, China
Related Publications (2)
Messroghli DR, Radjenovic A, Kozerke S, Higgins DM, Sivananthan MU, Ridgway JP. Modified Look-Locker inversion recovery (MOLLI) for high-resolution T1 mapping of the heart. Magn Reson Med. 2004 Jul;52(1):141-6. doi: 10.1002/mrm.20110.
PMID: 15236377BACKGROUNDDing H, Fernandez-de-Manuel L, Schar M, Schuleri KH, Halperin H, He L, Zviman MM, Beinart R, Herzka DA. Three-dimensional whole-heart T2 mapping at 3T. Magn Reson Med. 2015 Sep;74(3):803-16. doi: 10.1002/mrm.25458. Epub 2014 Sep 19.
PMID: 25242141BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of kidney transplantation center
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 5, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2021
Last Updated
April 5, 2019
Record last verified: 2019-04