Heart TransplantNCT04966988
Multimodal Imaging Evaluation and Prognostic Analysis of Cardiac Allograft Vasculopathy in Heart Transplantation
An observational study of Heart Transplant, run by Xie Mingxing.
Trial summary
The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Transplant
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2026
- How long will I take part?
- 10 Years
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography for surveillance at their routine follow-up
Who may be able to join
- Heart transplantation after January 1st, 2015.
Who cannot join
- •Age < 18 years at the time of transplantation; Died within 48 h; Heart-lung transplantation; Heart/kidney transplantation; Re-transplanted within 7 days after transplantation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.
Read the detailed description
This study will enrolled 1000 HT patients, and the cardiac allograft vasculopathy will be evaluated by multimodal imaging technology. The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.
- Conditions
- Heart Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAV 0(Not significant) | No detectable angiographic lesion | |
| CAV 1 (Mild) | Angiographic left main (LM) <50%, or primary vessel with maximum lesion of <70%, or any branch stenosis <70% (including diffuse narrowing) without allograft dysfunction | |
| CAV 2 (Moderate) | Angiographic LM <50%; a single primary vessel≥70%, or isolated branch stenosis ≥70% in branches | |
| CAV 3 (Severe) | Angiographic LM≥50%, or two or more primary vessels ≥70% stenosis, or isolated branch stenosis≥70%in all 3 systems; or CAV1 or CAV2 with allograft dysfunction (defined as LVEF≤45% usually in the presence of regional wall motion abnormalities) or evidence of significant restrictive physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records
Measured: up to 10 year
Secondary outcomes (1)
Major adverse cardiac events
Major adverse cardiac events after the inclusion of the study was obtained via telephone interview with family members; contact with his/her physicians; or hospital records
Measured: 5 year and 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Xie Mingxing
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Xie Mingxing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Li Zhang, PhD, Principal investigator, Department of Ultrasound, Union Hospital, Wuhan, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966988
- Sponsor's protocol ID
- 2021 V 1.0
- Status last verified
- Jul 2021
- First submitted
- 10 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT04966988
- Acronym / sponsor ID
- 2021 V 1.0
- Conditions
- Heart Transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xie MingxingUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Shanghai Zhongshan Hospital, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Jul 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.
The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.
Detailed description
This study will enrolled 1000 HT patients, and the cardiac allograft vasculopathy will be evaluated by multimodal imaging technology. The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CAV 0(Not significant) | – | –No detectable angiographic lesion |
| CAV 1 (Mild) | – | –Angiographic left main (LM) <50%, or primary vessel with maximum lesion of <70%, or any branch stenosis <70% (including diffuse narrowing) without allograft dysfunction |
| CAV 2 (Moderate) | – | –Angiographic LM <50%; a single primary vessel≥70%, or isolated branch stenosis ≥70% in branches |
| CAV 3 (Severe) | – | –Angiographic LM≥50%, or two or more primary vessels ≥70% stenosis, or isolated branch stenosis≥70%in all 3 systems; or CAV1 or CAV2 with allograft dysfunction (defined as LVEF≤45% usually in the presence of regional wall motion abnormalities) or evidence of significant restrictive physiology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography for surveillance at their routine follow-up
Key inclusion criteria (1 listed)
- Heart transplantation after January 1st, 2015.
Key exclusion criteria (1 listed)
- •Age < 18 years at the time of transplantation; Died within 48 h; Heart-lung transplantation; Heart/kidney transplantation; Re-transplanted within 7 days after transplantation.
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
All cause death
Time frame: up to 10 year
All cause death after HT was obtained via telephone interview with family members; contact with his/her physicians; or hospital records
1 secondary outcome
Major adverse cardiac events
Time frame: 5 year and 10 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Li Zhang, PhD principal investigator
Department of Ultrasound, Union Hospital, Wuhan, China
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by Xie Mingxing.
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 1 inclusion and 1 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Li Zhang, PhD (18907131488, zli429@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: up to 10 year). 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 19 Jul 2021.