Cardiovascular Outcomes and Risk Evaluation Among Recipients of Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Disqualifiers
Any other conditions that, in the opinion of the investigator, can interfere with the interpretation of data.
Patient request to withdraw from the study.
Trial population
Patients who undergo hematopoietic cell transplantation at any of the participating medical centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 1 trial groupGroup A: Patients undergoing hematopoietic stem cell transplantation
Trial outcomes
Primary outcomes
1
Major adverse cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) after 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.Secondary outcomes
1
Cardiovascular events
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.
Time frame
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.2
Overall survival
Overall survival after 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.3
Event-free survival
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.
Time frame
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.4
Complications of 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.
Time frame
At 30 days, 100 days, 3 months, 6 months, 1 years, 3 years, 5 years post hematopoietic stem cell transplantation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Tongji Hospital
Collaborator
Xinqiao hospital of the third military medical university
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Sun Yat-Sen University Cancer Center
Collaborator
Sichuan Provincial People's Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
Peking University Shenzhen Hospital
Collaborator
Peking University Third Hospital
Collaborator
Peking University First Hospital
Collaborator
Source ClinicalTrials.gov