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

NCT02401854 | Completed

• 1 other identifier: ASSERT-III
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 4

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.

Conditions

Elderly; Hypertension; Risk Factors for Atrial Fibrillation

Keywords

atrial fibrillation; hypertension; risk factors; primary care; elderly

Outcome Measures

Primary Outcomes (1)

• Occurance of atrial fibrillation episode

  Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration

  within 30 - 60 days of follow-up

Secondary Outcomes (3)

• Tolerability and feasibility of long term monitoring in elderly patients

  30 - 60 days of follow-up

• Proportion of patients eligible to receive anticoagulation

  30 - 60 days of follow-up

• AF Burden

  30 - 60 days of follow-up

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 80 years
• History of hypertension OR a blood pressure of ≥ 140/90 mmHg
• Attending a primary care clinic, OR ambulatory resident of a chronic care facility
• At least one of the following additional risk factors for developing AF:
• Diabetes
• Body mass index ≥ 30
• History of smoking
• Documented Obstructive sleep apnea
• Cardiovascular disease
• Heart Failure
• Left ventricular hypertrophy (on ECG or echocardiography)
• Provide written informed consent

You may not qualify if:

• ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes
• Existing implanted pacemaker or defibrillator
• Patients considered by the investigator to be unsuitable for study follow-up because the patient:
• is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
• has a life expectancy less that the expected study duration due to concomitant disease
• has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -

Sponsors & Collaborators

• Population Health Research Institute: lead
• Pfizer: collaborator
• M-Health Solutions: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (4)

AVIVA Medical Diagnostics and Specialist Clinic Inc.

Burlington, Ontario, L7R 1E2, Canada

Location

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

Family Practice - Drs. Cameron, Crombie & Croft

Hamilton, Ontario, Canada

Location

OakMed Family Health Team

Oakville, Ontario, L6H 7S8, Canada

Location

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff Healey, M.D.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Stuart Connolly, M.D.

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: March 30, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 4, 2025

Record last verified: 2015-04

Locations

CA (4)