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Trial record 1 of 2 for:    ASSERT III
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Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder (ASSERT-III)

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ClinicalTrials.gov Identifier: NCT02401854
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : April 28, 2015
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
M-Health Solutions
Information provided by (Responsible Party):
Jeff Healey, Population Health Research Institute

Study Description
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Brief Summary:
The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.

Condition or disease
Elderly Hypertension Risk Factors for Atrial Fibrillation

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder Using Automatic Algorithms for AF Detection: A Pilot Study (ASSERT-III)
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Occurance of atrial fibrillation episode [ Time Frame: within 30 - 60 days of follow-up ]
    Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration


Secondary Outcome Measures :
  1. Tolerability and feasibility of long term monitoring in elderly patients [ Time Frame: 30 - 60 days of follow-up ]
    The tolerability of long-term monitoring in elderly patients and the ability of these patients to manually transmit data to the cardiac analyses centre.

  2. Proportion of patients eligible to receive anticoagulation [ Time Frame: 30 - 60 days of follow-up ]
  3. AF Burden [ Time Frame: 30 - 60 days of follow-up ]
    An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF.


Eligibility Criteria
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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
elderly patients attending primary care clinic or ambulatory resident of a chronic care facility, with hypertension and at least one addional risk factor for developing AF.
Criteria

Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the following:

  1. Age ≥ 80 years
  2. History of hypertension OR a blood pressure of ≥ 140/90 mmHg
  3. Attending a primary care clinic, OR ambulatory resident of a chronic care facility

  4. At least one of the following additional risk factors for developing AF:

    1. Diabetes
    2. Body mass index ≥ 30
    3. History of smoking
    4. Documented Obstructive sleep apnea
    5. Cardiovascular disease
    6. Heart Failure
    7. Left ventricular hypertrophy (on ECG or echocardiography)
  5. Provide written informed consent

Exclusion Criteria:

  1. ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes
  2. Existing implanted pacemaker or defibrillator

  3. Patients considered by the investigator to be unsuitable for study follow-up because the patient:

    1. is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
    2. has a life expectancy less that the expected study duration due to concomitant disease
    3. has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401854


Locations
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Canada, Ontario
AVIVA Medical Diagnostics and Specialist Clinic Inc.
Burlington, Ontario, Canada, L7R 1E2
Hamilton Medical Research Group
Hamilton, Ontario, Canada, L8M 1K7
Family Practice - Drs. Cameron, Crombie & Croft
Hamilton, Ontario, Canada
OakMed Family Health Team
Oakville, Ontario, Canada, L6H 7S8
Sponsors and Collaborators
Population Health Research Institute
Bristol-Myers Squibb
Pfizer
M-Health Solutions
Investigators
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Principal Investigator: Jeff Healey, M.D. Population Health Research Institute
Principal Investigator: Stuart Connolly, M.D. Population Health Research Institute
More Information
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Additional Information:

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Responsible Party: Jeff Healey, Co-Principal Investigator, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02401854    
Other Study ID Numbers: ASSERT-III
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Jeff Healey, Population Health Research Institute:
atrial fibrillation
hypertension
risk factors
primary care
elderly
Additional relevant MeSH terms:
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Hypertension
Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
 Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes