Research on Patients With Heart Transplantation

Heart Transplant Rejection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04921774
• Other study ID #: 81771799
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 to improve the patient's prognosis.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. All patients after orthotopic heart transplantation.

2. All patients has signed informed consent.

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.

Related Conditions & MeSH terms

• Heart Transplant Rejection

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 6 months after surgery
Secondary	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.	At 6 months after surgery