Cardio-oncologyEIECCNCT05150080
Early Identification and Evaluation of Cyclophosphamide Cardiotoxicity
An observational study of Cardio-oncology and Hematopoietic Stem Cell Transplantation, run by Kai Mu at 1 site in China.
Trial summary
Hematopoietic stem cell transplantation is an important method for the treatment of hematological diseases and cyclophosphamide is a commonly used chemotherapeutic agent for transplant pretreatment. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Cardio-oncology, Hematopoietic Stem Cell Transplantation, Cardiotoxicity
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to 1 Jun 2022
- 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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with hematopoietic stem cell transplantation received high dose cyclophosphamide(>120mg/kg)
Who may be able to join
- Age ≤14 years old;
- Bone marrow/umbilical blood HCT received high dose cyclophosphamide(>120mg/kg) ；
- ECOG≤2;
- Sign an informed consent form (<10 years old, signed by the guardian; ≥10 years old, signed by the child and guardian).
Who cannot join
- Past myocarditis, cardiomyopathy, valvular heart disease, rheumatic heart disease, severe arrhythmia, heart failure, congenital heart disease history;
- Have heart or pericardial surgery;
- Have received radiotherapy involving thoracic cavity；
- Those who do not meet the above entry criteria.
Trial locations and contacts
1 site in 1 country.
ZHANG Jing contact
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital (The First Affiliated Hospital of Shandong First Medical University)
Jinan, Shandong, 251400
MU Kai, Doctor, 15634883957, mkbest@yeah.net
About this study
Official title: Early Identification and Evaluation of the Cardiotoxicity of Cyclophosphamide in Hematopoietic Stem Cell Transplantation : Based on Spot Tracking Ultrasound
Hematopoietic stem cell transplantation is an important method for the treatment of hematological diseases and cyclophosphamide is a commonly used chemotherapeutic agent for transplant pretreatment. The incidence of severe cardiovascular events after high-dose cyclophosphamide exposure ranges from 7% to 28% with mortality from 11% to 43%. Thus, an non-invasive, sensitive and reliable method in detecting cardiac function is significant to balance the cardiac risk and the potential cancer treatment benefits. In previous studies, we demonstrated that strain values analyzed by speckle tracking echocardiography decreased significantly after high-dose cyclophosphamide exposure, even though left ventricular ejection fraction remained stable and within normal range. We follow up the hematopoietic cell transplantation patients with cyclophosphamide: to analyze the cut-off values of the parameters of speckle tracking multilayer analysis in predicting early cardiotoxicity induced by cyclophosphamide; to detect the cut-off values of the plasma miRNAs levels in predicting early cardiotoxicity induced by anthracycline.
The purpose of our study is to find out non-invasive, reliable and sensitive echocardiographic parameters and plasma biomarkers for early detection and prediction cyclophosphamide -induced cardiac toxicity and to be helpful to target patients at high risk of cardiotoxicity, who could benefit from closer monitoring or earlier initiation of cardioprotective therapy.
Read the detailed description
After obtaining the informed consent of the research subjects, collect the following data of the research subjects: demographic information, clinical symptoms, family history and clinical diagnosis. Patients were tested for troponin, atrial natriuretic peptide, concurrent conventional electrocardiogram, conventional echocardiogram, speckle tracking echocardiography at spots 1 day before cyclophosphamide treatment, 2 days after cyclophosphamide infusion, and 10 days after cyclophosphamide infusion. ethylenediaminetetraacetic acid anticoagulated whole blood were saved and extract the blood cells from the sample bank and freeze them for RNA sequencing. The two-dimensional cardiac ultrasound image acquisition complies with the guidelines of the American Echocardiography Association, and the two-dimensional speckle tracking echocardiography acquisition is 4 cardiac cycles. If a cardiotoxic event occurs during this period, an electrocardiogram, conventional echocardiogram, and speckle tracking echocardiography should be performed within 24 hours.
Analyze the correlation between miRNA and clinical events of cardiotoxicity, and evaluate the predictive threshold of cardiotoxicity in children with high-dose cyclophosphamide chemotherapy.Evaluate the weight of miRNA in predicting cardiac damage, combined with serum biomarkers, construct a model for Predicting the risk of myocardial damage based on speckle tracking echocardiography parameters, serum biomarkers, and miRNA expression.
- Conditions
- Cardio-oncology, Hematopoietic Stem Cell Transplantation, Cardiotoxicity, Cyclophosphamide, Echocardiography
- Keywords
- Cardio-oncology, Speckle tracking echocardiography
- Medical subject headings
- Cardiotoxicity
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 |
|---|---|---|
| cardiotoxicity | subjects with heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation. | |
| non-cardiotoxicity | subjects with on heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity
changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity at the follow-up point
Measured: From the start of cyclophosphamide injection to1 month after the completion of injection
Secondary outcomes (1)
changes of miRNA between cardiotoxicity group and No cardiotoxicity
changes of miRNA between cardiotoxicity group and No cardiotoxicity
Measured: From the start of cyclophosphamide injection to1 month after the completion of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Jul 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-oncologyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Mu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Mu, Qianfoshan Hospital
- Investigators
- MU Kai, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150080
- Sponsor's protocol ID
- QianfoshanH-210118
- Acronym
- EIECC
- Status last verified
- Nov 2021
- First submitted
- 27 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Evaluation of the Cardiotoxicity of Cyclophosphamide in Hematopoietic Stem Cell Transplantation : Based on Spot Tracking Ultrasound
- ClinicalTrials.gov ID
- NCT05150080
- Acronym / sponsor ID
- EIECC / QianfoshanH-210118
- Conditions
- Cardio-oncology, Hematopoietic Stem Cell Transplantation, Cardiotoxicity, Cyclophosphamide, Echocardiography
- Keywords
- Cardio-oncology, Speckle tracking echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kai MuUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Dec 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.
Hematopoietic stem cell transplantation is an important method for the treatment of hematological diseases and cyclophosphamide is a commonly used chemotherapeutic agent for transplant pretreatment. The incidence of severe cardiovascular events after high-dose cyclophosphamide exposure ranges from 7% to 28% with mortality from 11% to 43%. Thus, an non-invasive, sensitive and reliable method in detecting cardiac function is significant to balance the cardiac risk and the potential cancer treatment benefits. In previous studies, we demonstrated that strain values analyzed by speckle tracking echocardiography decreased significantly after high-dose cyclophosphamide exposure, even though left ventricular ejection fraction remained stable and within normal range. We follow up the hematopoietic cell transplantation patients with cyclophosphamide: to analyze the cut-off values of the parameters of speckle tracking multilayer analysis in predicting early cardiotoxicity induced by cyclophosphamide; to detect the cut-off values of the plasma miRNAs levels in predicting early cardiotoxicity induced by anthracycline.
The purpose of our study is to find out non-invasive, reliable and sensitive echocardiographic parameters and plasma biomarkers for early detection and prediction cyclophosphamide -induced cardiac toxicity and to be helpful to target patients at high risk of cardiotoxicity, who could benefit from closer monitoring or earlier initiation of cardioprotective therapy.
Detailed description
After obtaining the informed consent of the research subjects, collect the following data of the research subjects: demographic information, clinical symptoms, family history and clinical diagnosis. Patients were tested for troponin, atrial natriuretic peptide, concurrent conventional electrocardiogram, conventional echocardiogram, speckle tracking echocardiography at spots 1 day before cyclophosphamide treatment, 2 days after cyclophosphamide infusion, and 10 days after cyclophosphamide infusion. ethylenediaminetetraacetic acid anticoagulated whole blood were saved and extract the blood cells from the sample bank and freeze them for RNA sequencing. The two-dimensional cardiac ultrasound image acquisition complies with the guidelines of the American Echocardiography Association, and the two-dimensional speckle tracking echocardiography acquisition is 4 cardiac cycles. If a cardiotoxic event occurs during this period, an electrocardiogram, conventional echocardiogram, and speckle tracking echocardiography should be performed within 24 hours.
Analyze the correlation between miRNA and clinical events of cardiotoxicity, and evaluate the predictive threshold of cardiotoxicity in children with high-dose cyclophosphamide chemotherapy.Evaluate the weight of miRNA in predicting cardiac damage, combined with serum biomarkers, construct a model for Predicting the risk of myocardial damage based on speckle tracking echocardiography parameters, serum biomarkers, and miRNA expression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardiotoxicity | – | –subjects with heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation. |
| non-cardiotoxicity | – | –subjects with on heart failure, coronary artery disease, valvular heart disease, arrhythmia, hypertension, thromboembolic disease, peripheral vascular disease and stroke, pulmonary hypertension and pericardial disease after hematopoietic stem cell transplantation. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with hematopoietic stem cell transplantation received high dose cyclophosphamide(>120mg/kg)
Key inclusion criteria (4 listed)
- Age ≤14 years old;
- Bone marrow/umbilical blood HCT received high dose cyclophosphamide(>120mg/kg) ；
- ECOG≤2;
- Sign an informed consent form (<10 years old, signed by the guardian; ≥10 years old, signed by the child and guardian).
Key exclusion criteria (4 listed)
- Past myocarditis, cardiomyopathy, valvular heart disease, rheumatic heart disease, severe arrhythmia, heart failure, congenital heart disease history;
- Have heart or pericardial surgery;
- Have received radiotherapy involving thoracic cavity；
- Those who do not meet the above entry criteria.
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
changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity
Time frame: From the start of cyclophosphamide injection to1 month after the completion of injection
changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity at the follow-up point
1 secondary outcome
changes of miRNA between cardiotoxicity group and No cardiotoxicity
Time frame: From the start of cyclophosphamide injection to1 month after the completion of injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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.
ZHANG Jing contact
MU Kai study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-oncology and Hematopoietic Stem Cell Transplantation, run by Kai Mu at 1 site in China.
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 4 inclusion and 4 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 MU Kai (15634883957, mkbest@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of global longitudinal strain value between cardiotoxicity group and No cardiotoxicity (time frame: From the start of cyclophosphamide injection to1 month after the completion of injection). 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 8 Dec 2021.