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Cardiovascular Disorders and Risk Factors in Childhood Cranial and Craniospinal Tumors Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05641636
Recruitment Status : Completed
First Posted : December 7, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
I.M. Sechenov First Moscow State Medical University

Brief Summary:
The purpose of research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors. In this research the investigators investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after cranial and craniospinal radiotherapy and chemotherapy.

Condition or disease Intervention/treatment
Tumors of the Central Nervous System Childhood Cancer Survivors Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Cardiovascular Disorders and Risk Factors in Childhood Cranial and Craniospinal Tumors Survivors
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : December 30, 2021
Actual Study Completion Date : October 28, 2022

Group/Cohort Intervention/treatment
childhood cancer survivors - the main group
childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group
Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis
Echocardiography - standart protocol. Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH). CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance.

the control group
healthy people formed the control group
Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis
Echocardiography - standart protocol. Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH). CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance.




Primary Outcome Measures :
  1. Dyslipidemia [ Time Frame: At baseline and through study completion of 1 year ]
    change сoncentration of total cholesterol >5 mmol/l, change сoncentration of LDL > 3 mmol/l, сoncentration of HDL <1,2 mmol/l, change сoncentration of TG >1,7 mmol/

  2. endotelian dysfunction [ Time Frame: At baseline and through study completion of 1 year ]
    change in endothelial function by Angioscan

  3. change in exercise tolerance [ Time Frame: At baseline and through study completion of 1 year ]
    change anaerobic threshold<14,0 ml/kg/min



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group
Criteria

Inclusion Criteria:

  • radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence
  • completion of the therapy at least one year before enrollment
  • signed informed consent
  • there were three separate types of informed consent - for adults, for minors and for their parents
  • minors were signing informed consent in the presence of their parents.

Exclusion Criteria:

  • standard contraindications to exercise testing
  • anemia, pregnancy
  • psychiatric disease
  • alcohol or drug abuse
  • active malignancy
  • acute infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641636


Locations
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Russian Federation
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russian Federation
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Additional Information:
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Responsible Party: I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT05641636    
Other Study ID Numbers: A-3011
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I.M. Sechenov First Moscow State Medical University:
brain tumors in children
risk of cardiovascular disease
radiation therapy
dyslipidemia
endothelial dysfunction
cardiopulmonary testing
Additional relevant MeSH terms:
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Central Nervous System Neoplasms
Cardiovascular Diseases
Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs