Simultaneous Pancreas-kidney TransplantationAMI-SPKNCT03904485
Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation
An observational study of Simultaneous Pancreas-kidney Transplantation and Diabetic Cardiomyopathy, run by Tianjin First Central Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Simultaneous Pancreas-kidney Transplantation, Diabetic Cardiomyopathy
- What is being tested?
- cardiac magnetic resonance(CMR) T2 mapping
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),
- Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.
- Being tested
- cardiac magnetic resonance(CMR) T2 mapping
- Keywords
- SPK ,DCM,CMR
- Medical subject headings
- Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance(CMR) T2 mappingRadiation
T2 value before transplant，3 month and 6month after transplant
| Study group | Role | What they receive |
|---|---|---|
| SPKT | patients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation Receives: Radiation: cardiac magnetic resonance(CMR) T2 mapping | |
| RT | patients with end-stage diabetic nephropathy got single kidney transplantation Receives: Radiation: cardiac magnetic resonance(CMR) T2 mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of myocardial injury
Assessment of myocardial injury between two groups
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Simultaneous Pancreas-kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingxin FU.MD, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904485
- Sponsor's protocol ID
- 2019N020KY
- Acronym
- AMI-SPK
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study data including numbers, clinical data, and corresponding CMR results, were shared every three months
Publications
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.
PubMed 15236377Ding 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.
PubMed 25242141
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Injury in Recipients of Simultaneous Pancreas and Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03904485
- Acronym / sponsor ID
- AMI-SPK / 2019N020KY
- Keywords
- SPK ,DCM,CMR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),
- Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPKT | – | Radiation: cardiac magnetic resonance(CMR) T2 mappingpatients with end-stage diabetic nephropathy got simultaneous pancreas-kidney transplantation |
| RT | – | Radiation: cardiac magnetic resonance(CMR) T2 mappingpatients with end-stage diabetic nephropathy got single kidney transplantation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac magnetic resonance(CMR) T2 mappingT2 value before transplant，3 month and 6month after transplant | Radiation | RT, SPKT |
Primary outcome
Assessment of myocardial injury
Time frame: 1year
Assessment of myocardial injury between two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 15236377Messroghli 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.
- Background: PubMed 25242141Ding 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.
- Individual participant dataSharing planned: Undecided. Study data including numbers, clinical data, and corresponding CMR results, were shared every three months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simultaneous Pancreas-kidney Transplantation and Diabetic Cardiomyopathy, run by Tianjin First Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of myocardial injury (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03904485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.