NCT04921774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

4 years

First QC Date

June 1, 2021

Last Update Submit

August 7, 2022

Conditions

Heart Transplant Rejection

Keywords

Magnetic Resonance ImagingMultimodalityHeart TransplantationExosome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients after orthotopic heart transplantation.

You may qualify if:

  • All patients after orthotopic heart transplantation.
  • All patients has signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 5100, China

Location

Study Officials

  • Hui Liu, MD

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 10, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

CN(1)