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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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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.

Find a Location

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

Wireless Synchronized Cardiac Function Monitoring Device (Cardiac Monitoring Device) Clinical Trial Eligibility Overview. Trial Name: NCT05138991 — N/A
Blood Cancers Research Study Groups: Screening (echo, CMR, Tonometry-based system)
Blood Cancers Clinical Trial 2023: Wireless Synchronized Cardiac Function Monitoring Device Highlights & Side Effects. Trial Name: NCT05138991 — N/A
Wireless Synchronized Cardiac Function Monitoring Device (Cardiac Monitoring Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138991 — N/A

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
~43 spots leftby Nov 2024