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Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

This study has been terminated.
(Lack of accrual)
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01253590
First received: December 2, 2010
Last updated: November 11, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Post-Operative Cancer Patients Experiencing Atrial
Fibrillation
 Behavioral: questionnaire about the use of ECG device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Remote Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Assess the feasibility and acceptance of continuous remote cardiac monitoring [ Time Frame: 4 to 6 weeks ] [ Designated as safety issue: No ]
    In post-operative patients with respect to recurrence of post-operative atrial fibrillation upon discharge.


Enrollment: 5
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
post op cancer patients experiencing atrial fibrillation
This small study aims to assess the feasibility and acceptance of remote cardiac monitoring of postoperative cancer patients experiencing atrial fibrillation and will collect continuous data on heart beat over a period of 4-6 weeks upon discharge.
 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.
Other Names:
  • Upon obtaining written informed consent, a technician from Ocean Empire
  • Diagnostic & Monitoring Group will equip the participant with the ECG device and
  • demonstrate the use. This is standard practice at MSKCC for 24 hour holters
  • and we will be using the same company to equip patients with the ECG device.
  • Participants will also be equipped with a blood pressure device for use at
  • home during the 4-6 week period and the RN will demonstrate its use.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Two cardiology attending physicians, Dr. Michelle Johnson and Dr. Carol L. Chen, who are members of this research team, will identify post-operative patients whose primary attending has made a decision to discharge.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253590

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Michelle Johnson, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01253590     History of Changes
Other Study ID Numbers: 10-213
Study First Received: December 2, 2010
Last Updated: November 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
atrial fibrillation
ECG monitor
Blood pressure device
Remote Cardiac Monitoring

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013