Clinical trial NCT04921774: Research on Patients With Heart Transplantation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Rejection
Keywords: Magnetic Resonance Imaging
Multimodality
Heart Transplantation
Exosome
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients after orthotopic heart transplantation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
timeFrame: At 6 months after surgery
Secondary outcomes:
measure: Specificity of combining multimodality MR Imaging with circulating exosomal miRNA expression in evaluating acute rejection in patients with heart transplantation.
timeFrame: At 6 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Hui Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: