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

NCT05641636 | Completed DMC

• 1 other identifier: A-3011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors of the Central Nervous System; Childhood Cancer Survivors

Keywords

brain tumors in children; risk of cardiovascular disease; radiation therapy; dyslipidemia; endothelial dysfunction; cardiopulmonary testing

Outcome Measures

Primary Outcomes (3)

• Dyslipidemia

  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/

  At baseline and through study completion of 1 year

• endotelian dysfunction

  change in endothelial function by Angioscan

  At baseline and through study completion of 1 year

• change in exercise tolerance

  change anaerobic threshold\<14,0 ml/kg/min

  At baseline and through study completion of 1 year

Study Arms (2)

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

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

Interventions

12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis DIAGNOSTIC_TEST

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.

childhood cancer survivors - the main group; the control group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Dyslipidemias

Interventions

Electrocardiography; Echocardiography; Exercise Test; Pulse Wave Analysis

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 7, 2022
• Study Start: November 11, 2019
• Primary Completion: December 30, 2021
• Study Completion: October 28, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)