Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder

NCT02401854

Last updated date
Study Location
AVIVA Medical Diagnostics and Specialist Clinic Inc.
Burlington, Ontario, L7R 1E2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Elderly, Hypertension, Risk Factors for Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
80 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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 -

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Elderly, Hypertension, Risk Factors for Atrial FibrillationPrevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder
NCT02401854
  1. Burlington, Ontario
  2. Hamilton, Ontario
  3. Hamilton, Ontario
  4. Oakville, Ontario
ALL GENDERS
80 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder
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)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 60 Days
Biospecimen Not Provided
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.
Condition
  • Elderly
  • Hypertension
  • Risk Factors for Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 27, 2015)
129
Original Estimated Enrollment
 (submitted: March 24, 2015)
150
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility 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 -
Sex/Gender
Sexes Eligible for Study:All
Ages 80 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02401854
Other Study ID Numbers ASSERT-III
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jeff Healey, Population Health Research Institute
Study Sponsor Population Health Research Institute
Collaborators
  • Bristol-Myers Squibb
  • Pfizer
  • M-Health Solutions
Investigators
Principal Investigator:Jeff Healey, M.D.Population Health Research Institute
Principal Investigator:Stuart Connolly, M.D.Population Health Research Institute
PRS Account Population Health Research Institute
Verification Date April 2015