Heart Transplant RejectionNCT04921774
Research on Patients With Heart Transplantation
An observational study of Heart Transplant Rejection, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This trial was a single-center, prospective cohort study.The purpose of this clinical research is to evaluate the accuracy of combining multimodality MR Imaging with circulating exosomal miRNA expression to diagnose acute rejection in patients with heart transplantation，thus it may be helpful for timely intervention… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplant Rejection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients after orthotopic heart transplantation.
Who may be able to join
- All patients after orthotopic heart transplantation.
- All patients has signed informed consent.
Who cannot join
- Patients with early graft failure within 24-48h after transplantation requiring clinical support or intensive care treatment.
- Patients with severe renal failure.
- Patients with any general contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research on the Pathogenesis and Early Diagnosis of Acute Rejection in Patients With Heart Transplantation by Using Multimodality MR Imaging Combined With Circulating Exosomal miRNA Expression
This trial was a single-center, prospective cohort study.The purpose of this clinical research is to evaluate the accuracy of combining multimodality MR Imaging with circulating exosomal miRNA expression to diagnose acute rejection in patients with heart transplantation，thus it may be helpful for timely intervention to improve the patient's prognosis.
Read the detailed description
Acute rejection (AR) after heart transplantation remains the major factor limiting long-term survival, and an independent risk factor for chronic allograft vasculopathy. Currently, there remains no reliable non-invasive method to detect AR. Multimodality magnetic resonance (MR) imaging shows accurate detection of myocardial damage, such as interstitial cell infiltrates, edema, hemorrhage, myocyte damage/necrosis and capillary stenosis or fragmentation. It turned out that the indicators in both MR imaging and circulating exosomal miRNA showed difference between patients with and without AR in our initial research work. Therefore, we hypothesize that circulating exosomal miRNA may play an important role in the activation of signaling pathway in AR after heart transplantation, which can be detected by multimodality MR imaging. All transplant recipients receiving transplantation follow-up care in our center were approached. In the present research we aim to combine multimodality MR imaging with circulating exosomal miRNA to explore a new evaluation methodology and platform for early and noninvasive detection of AR after heart transplantation. We attempt to confirm contribution of circulating exosomal miRNA to myocardial damage of AR through biopsy-proven allograft rejection and animal heterotopic heart transplantation.
- Conditions
- Heart Transplant Rejection
- Keywords
- Magnetic Resonance Imaging, Multimodality, Heart Transplantation, Exosome
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
defined as the model's capability of accurately identifying patients who will have acute rejection.
Measured: At 6 months after surgery
Secondary outcomes (1)
Specificity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
defined as the model's capability of accurately identifying patients who will not have acute rejection.
Measured: At 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Guangdong Provincial People's Hospital
- Investigators
- Hui Liu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921774
- Sponsor's protocol ID
- 81771799
- Status last verified
- Aug 2022
- First submitted
- 1 Jun 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Pathogenesis and Early Diagnosis of Acute Rejection in Patients With Heart Transplantation by Using Multimodality MR Imaging Combined With Circulating Exosomal miRNA Expression
- ClinicalTrials.gov ID
- NCT04921774
- Acronym / sponsor ID
- 81771799
- Conditions
- Heart Transplant Rejection
- Keywords
- Magnetic Resonance Imaging, Multimodality, Heart Transplantation, Exosome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Jun 2021 (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.
This trial was a single-center, prospective cohort study.The purpose of this clinical research is to evaluate the accuracy of combining multimodality MR Imaging with circulating exosomal miRNA expression to diagnose acute rejection in patients with heart transplantation，thus it may be helpful for timely intervention to improve the patient's prognosis.
Detailed description
Acute rejection (AR) after heart transplantation remains the major factor limiting long-term survival, and an independent risk factor for chronic allograft vasculopathy. Currently, there remains no reliable non-invasive method to detect AR. Multimodality magnetic resonance (MR) imaging shows accurate detection of myocardial damage, such as interstitial cell infiltrates, edema, hemorrhage, myocyte damage/necrosis and capillary stenosis or fragmentation. It turned out that the indicators in both MR imaging and circulating exosomal miRNA showed difference between patients with and without AR in our initial research work. Therefore, we hypothesize that circulating exosomal miRNA may play an important role in the activation of signaling pathway in AR after heart transplantation, which can be detected by multimodality MR imaging. All transplant recipients receiving transplantation follow-up care in our center were approached. In the present research we aim to combine multimodality MR imaging with circulating exosomal miRNA to explore a new evaluation methodology and platform for early and noninvasive detection of AR after heart transplantation. We attempt to confirm contribution of circulating exosomal miRNA to myocardial damage of AR through biopsy-proven allograft rejection and animal heterotopic heart transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients after orthotopic heart transplantation.
Key inclusion criteria (2 listed)
- All patients after orthotopic heart transplantation.
- All patients has signed informed consent.
Key exclusion criteria (3 listed)
- Patients with early graft failure within 24-48h after transplantation requiring clinical support or intensive care treatment.
- Patients with severe renal failure.
- Patients with any general contraindication to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
Time frame: At 6 months after surgery
defined as the model's capability of accurately identifying patients who will have acute rejection.
1 secondary outcome
Specificity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
Time frame: At 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
Hui Liu, MD principal investigator
Guangdong Provincial People's Hospital
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 Heart Transplant Rejection, run by Guangdong Provincial People's 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 2 inclusion and 3 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 9 Aug 2022. 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?
Sensitivity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation. (time frame: At 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.