Research on Patients With Heart Transplantation

• Conditions: Heart Transplant Rejection

• Registration Number: NCT04921774
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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 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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-07
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. All patients after orthotopic heart transplantation.
2. All patients has signed informed consent.

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Exclusion Criteria

1. Patients with early graft failure within 24-48h after transplantation requiring clinical support or intensive care treatment.
2. Patients with severe renal failure.
3. Patients with any general contraindication to MRI.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.	At 6 months after surgery	defined as the model's capability of accurately identifying patients who will have acute rejection.

Secondary Outcome Measures

Name	Time	Method
Specificity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.	At 6 months after surgery	defined as the model's capability of accurately identifying patients who will not have acute rejection.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China