Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03911986 |
| Other study ID # |
17-CRFG 17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 21, 2018 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
National University of Ireland, Galway, Ireland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
1. To determine whether a risk-based screening programme for occult paroxysmal atrial
fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of
3 or greater, increases the detection of new atrial fibrillation/flutter.
2. To determine whether a risk-based screening programme for occult paroxysmal atrial
fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of
3 or greater, is cost-effective.
3. To determine the sensitivity, specificity, positive predictive value and negative
predictive values of self-monitoring of pulse in adults for detection of atrial
fibrillation.
4. To determine the cost, cost effectiveness, and budget impact of a risk-based screening
programme for occult paroxysmal atrial fibrillation, relative to a control of usual care
in general practice.
Description:
Stroke is a leading cause of death and disability. A first diagnosis of atrial fibrillation
may occur at the time of stroke (e.g. about 45% of patients with acute stroke). Undiagnosed
atrial fibrillation is therefore a major care-gap in stroke prevention.
Against this backdrop, oral anticoagulant therapy is extremely effective at reducing the risk
of ischemic stroke in atrial fibrillation, associated with a two-thirds risk reduction.
Therefore, a major care gap in stroke prevention is the prevalence of undetected atrial
fibrillation in the community. Traditional pulse screening in all patients > 65 years detects
new atrial fibrillation in about 1% of people.
The CHA2DS2-VASc score was developed and validated to risk-stratify patients with atrial
fibrillation into low, intermediate and high risk of stroke. The Investigators believe that
the CHA2DS2-VASc score represents an opportunity to identify patients at high risk of atrial
fibrillation, but also identifies this at highest risk of stroke, and therefore those that
will derive greatest benefit from anticoagulant therapy.
The advent of external-worn event loop recorders (ELRs) present a more convenient and
efficient method of detecting atrial fibrillation. Loop recorders have an in-built diagnostic
algorithm that identifies atrial fibrillation, and initiates recordings before and after the
event-trigger. This rhythm strip is then examined and confirmed by the trial cardiac
technician. The investigators will examine if using external loop recorders in patients
identified as high risk will improve the detection rate of paroxysmal atrial fibrillation.
The study is a randomised controlled cross-over multi-centered clinical trial in General
Practice. Ethical approval has been sought from the Galway University Hospitals research
ethics committee. The investigators have also engaged with Clinical Research Patient and
Public Involvement.
The investigators primary research question is whether extended cardiac rhythm monitoring
(with ELR for 1 week), compared to standard care, in patients pre-identified to be at
high-risk of atrial fibrillation (defined by CHA2DS2-VASc score >2) increases the detection
of new atrial fibrillation resulting in introduction of oral anticoagulant therapy, that is
efficient, acceptable to patients and cost-effective.
All participating general practices will require the Socrates software package. The
investigators will run analyses to identify patients with a CHA2DS2-VASc of 3 or greater. The
investigators will exclude all patients with known atrial fibrillation, those in whom
contraindications to oral anticoagulant therapy exist, and those who are deemed unsuitable
for extended monitoring.
