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Cardiac Monitoring Device
Portable Cardiac Monitoring for Childhood Cancer Survivors
N/A
Recruiting
Led By Saro H Armenian
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing how well two different portable devices detect early heart dysfunction, compared to other available tests. The devices can be used outside of the clinic, which may help detect problems earlier.
Who is the study for?
This trial is for childhood cancer survivors who were part of a previous study (IRB# 14154) and can consent to participate. It's not suitable for those currently on cancer treatment or with certain implants like pacemakers, insulin pumps, cochlear implants, aneurysm clips, neural stimulators, metal in the eye, or other medical devices.Check my eligibility
What is being tested?
The trial tests new portable systems (SphygmoCor® Xcel and Oscar 2™) against standard heart failure screenings like echocardiograms and cardiac MRIs. These devices could detect early heart issues from home use compared to traditional clinic-based tests.See study design
What are the potential side effects?
There are generally no side effects associated with using the SphygmoCor® Xcel and Oscar 2™ monitoring devices. However, stress during MRI may cause discomfort or anxiety; contrast agents used may lead to allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Accuracy of ejection fraction (EF) in the clinic setting, and determine its reproducibility at home.
Secondary outcome measures
Cost-effectiveness of tonometry-based screening in the clinic setting and at home.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Screening (echo, CMR, Tonometry-based system)Experimental Treatment4 Interventions
Patients undergo a one time assessment of cardiac function by echo, CMR, and the Tonometry-based system system in the clinic over 4-6 hours, and will be asked to perform their home-based measurements within 1-5 days of the clinical assessment, allowing us to directly compare measurements obtained by survivors to those by research personnel. Patients also complete questionnaires at baseline.
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,260 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,442 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Saro H ArmenianPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
1,266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any metal implants or devices in my body.I am not currently undergoing treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Screening (echo, CMR, Tonometry-based system)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for the study still open?
"That is correct. Currently, clinicaltrials.gov hosts information suggesting that this research endeavour, which began on June 22nd 2022, remains actively recruiting participants with a goal of 200 patients from one medical facility."
Answered by AI
What is the maximum capacity for participants in this research endeavor?
"Yes, according to clinicaltrials.gov, this medical study launched on June 22nd 2022 and is currently seeking volunteers. 200 patients will be recruited across a single site."
Answered by AI
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