Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation (AMI-SPK)

April 4, 2019 updated by: Yingxin FU.MD, Tianjin First Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • Tianjin First Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SPKT
patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation
Radiation: cardiac magnetic resonance(CMR) T2 mapping
T2 value before transplant，3 month and 6month after transplant
RT
patients with end-stage diabetic nephropathy got single kidney transplantation
Radiation: cardiac magnetic resonance(CMR) T2 mapping
T2 value before transplant，3 month and 6month after transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of myocardial injury
Time Frame: 1year
Assessment of myocardial injury between two groups
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin First Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019N020KY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study data including numbers, clinical data, and corresponding CMR results, were shared every three months

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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