Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT)

January 9, 2026 updated by: Xiao Hui Zhang, Peking University People's Hospital

Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation (CORE-HCT): A Prospective Multicenter Observational Study

This is a prospective, multicenter observational study for recipients of hematopoietic stem cell transplantation. Patients who underwent hematopoietic stem cell transplantation at the participating centers will be entrolled in the study. The clinical characteristics, laboratory profiles, management measures, and clinical outcomes such as post-transplant cardiovascular events will be prospectively collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Yu Jun Dong
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hong Mei Jing
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Dai Hong Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Xinqiao hospital of the third military medical university
        • Contact:
          • Xi Zhang
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center, Sun Yat-sen University
        • Contact:
          • Yang Liang
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Hong Yu Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Sheng Jin Fan
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Zhong Xing Jiang
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Ling Hui Xia
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Yi Cheng Zhang
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • First Affiliated Hospital Xi'an Jiaotong University
        • Contact:
          • Peng Cheng He
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Xiao Bing Huang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
        • Contact:
          • Er Lie Jiang
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • ming jiang
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University
        • Contact:
          • Yi Luo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.

Description

Inclusion Criteria:

  • Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.

Exclusion Criteria:

  • Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
  • Patient request to withdraw from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients undergoing hematopoietic stem cell transplantation
Patients who undergo allogeneic hematopoietic stem cell transplantation at participating medical center.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Major adverse cardiovascular events (MACE) after hematopoietic stem cell transplantation.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Cardiovascular events after hematopoietic stem cell transplantation, such as cardiovascular death, ischemic heart disease, coronary artery disease, stroke, heart failure, arrhythmia cardiomyopathy, myocarditis, endocarditis, valvular heart disease, and pericardial disease.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Overall survival after hematopoietic stem cell transplantation.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Event-free survival
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Events were defined as the occurrence of any of the following after allo-HSCT: grade III-IV acute graft-versus-host disease (GVHD), chronic GVHD requiring systemic immunosuppression, relapse or progression of the hematologic disease, or death from any cause during follow-up.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications of hematopoietic stem cell transplantation
Time Frame: At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.
Complications arising from hematopoietic stem cell transplantation range from early issues such as regimen toxicity and acute GVHD to late effects including chronic GVHD, organ dysfunction, and secondary malignancies.
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital
Chinese PLA General Hospital
Peking University Third Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
Peking University Shenzhen Hospital
First Affiliated Hospital of Xinjiang Medical University
Sichuan Provincial People's Hospital
First Affiliated Hospital of Harbin Medical University
Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Sun Yat-sen University Cancer Center, Sun Yat-sen University
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Xinqiao hospital of the third military medical university
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-z232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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