Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation

NCT ID: NCT03904485

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Simultaneous Pancreas-kidney Transplantation Diabetic Cardiomyopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SPKT

patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation

cardiac magnetic resonance(CMR) T2 mapping

Intervention Type RADIATION

T2 value before transplant,3 month and 6month after transplant

RT

patients with end-stage diabetic nephropathy got single kidney transplantation

cardiac magnetic resonance(CMR) T2 mapping

Intervention Type RADIATION

T2 value before transplant,3 month and 6month after transplant

Interventions

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cardiac magnetic resonance(CMR) T2 mapping

T2 value before transplant,3 month and 6month after transplant

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin First Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yingxin FU.MD

Director of kidney transplantation center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin First central hospital

Tianjin, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 15236377 (View on PubMed)

Ding 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.

Reference Type BACKGROUND
PMID: 25242141 (View on PubMed)

Other Identifiers

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2019N020KY

Identifier Type: -

Identifier Source: org_study_id

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