Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

Fibrillation Clinical Trial

Official title:

Feasibility of Remote Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01253590
• Other study ID #: 10-213
• Status: Terminated
• Phase: N/A
• First received: December 2, 2010
• Last updated: March 4, 2015
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess whether it is possible and acceptable to monitor patients at a distance who experience a condition called atrial fibrillation after their cancer surgery. Some patients have no other clinical reason for staying in the hospital after cancer surgery except in order to control their heart rhythm. Being able to send these patients home earlier and monitor them at a distance from their home can be good for their quick recovery. Studies have shown greater quality of life and patient satisfaction when patients are monitored at a distance for conditions like atrial fibrillation, however cancer patients have not been studied.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Post-Operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged.

• Must attend two outpatient visits at MSKCC's cardiology practice during the study period, as specified by the participant's Attending.

• Must be older than 21 years of age.

Exclusion Criteria:

• Non-English speaking patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrillation
• Post-Operative Cancer Patients Experiencing Atrial

Intervention

Behavioral:
• questionnaire about the use of ECG device
Patients will be fitted with a continuous ECG monitor and blood pressure device. Data on every heart beat, including episodes of atrial fibrillation, for 4-6 weeks of continuous monitoring will be collected and transmitted wirelessly. Based on this information and blood pressure readings performed by patients in their home setting, clinicians can adjust oral coagulant dosage. Participants will attend 2 follow-up outpatient visits at the MSKCC outpatient cardiology practice upon the cardiologist's recommendation. Upon completion of the study, 4-6 weeks, a questionnaire will be sent via mail, including a pre-paid envelope, to participants to assess feasibility, acceptance, and overall experience with remote cardiac monitoring.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasibility and acceptance of continuous remote cardiac monitoring	In post-operative patients with respect to recurrence of post-operative atrial fibrillation upon discharge.	4 to 6 weeks	No

External Links

•   Memorial Sloan Kettering Cancer Center