Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

Diabetic Cardiomyopathy Clinical Trial

— AMI-SPK  

Official title:

Assessment of Myocardial Injury in Recipients of Simultaneous Pancreas and Kidney Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03904485
• Other study ID #: 2019N020KY
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2019
• Source: Tianjin First Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

1. Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),

2. Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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

Exclusion Criteria:

1. Contraindications in cardiac magnetic resonance imaging;2.poorly controlled hypertension;3.CMR examination revealed marked hypertrophy of the left ventricular myocardium

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetic Cardiomyopathies
• Diabetic Cardiomyopathy
• Simultaneous Pancreas-kidney Transplantation

Intervention

Radiation:
• cardiac magnetic resonance(CMR) T2 mapping
T2 value before transplant,3 month and 6month after transplant

Locations

Country	Name	City	State
China	Tianjin First central hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Ding H, Fernandez-de-Manuel L, Schär 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of myocardial injury	Assessment of myocardial injury between two groups	1year