Clinical trial NCT05717504: Sweet spoT for cArdiac Rhythm monitorinG After sTrokE
Official title: STARGATE (Sweet spoT for cArdiac Rhythm monitorinG After sTrokE) Pilot Trial: A Pilot-feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Atrial Fibrillation
Keywords: Implantable Loop Recorder
Anticoagulant
Stroke
Atrial fibrillation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2023-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the use of long-term vs. shorter-term heart monitoring to detect atrial fibrillation after stroke.

Patients will be implanted with a loop recorder and will have study follow-up at 3-, 6- an 12-months after implantation.

The investigators will evaluate 24 patients, between the 3 centers, in the same way the investigators plan to evaluate a larger number of participants (\>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.

Detailed description: Atrial fibrillation (AF) is the most common heart rhythm disorder. Its name comes from the fibrillation (i.e. quivering) of the two upper chambers (atria) of the heart instead of a coordinated contraction, causing a rapid, irregular heart rate. This irregular contraction is ineffective, leading to the development clots in the heart. These clots can travel through the bloodstream until they get stuck in a brain artery. Millions of brain cells that depend on the oxygen supplied by the blocked artery die within minutes. This is known as a stroke. Strong blood thinners known as anticoagulants can lower stroke risk by 64% in AF patients when the AF is detected on an electrocardiogram (ECG) or if it lasts more than 24h on a heart monitor. Therefore, doctors use cardiac monitors to record the heartbeats of stroke patients for up to 3 years. It was historically thought, but not proven, that if AF was found in stroke patients, using anticoagulants could prevent a second stroke. However, recent information suggests that using cardiac monitors in stroke patients increases AF detection and anticoagulants prescription without a reduction in the number of new strokes. The failure to prevent a second stroke is likely the consequence of cardiac monitors sometimes detecting very short-duration AFs, which may have a low risk of stroke. If AFs last only for a few minutes or hours, anticoagulants may not be needed.

Patients with a stroke and not know atrial fibrillation will be implanted with a loop recorder and randomized in two groups (disclosure arm and non-disclosure arm). Patients will have phone follow-up visits at 3, 6 and 12 months after implantation. A quality-of-life survey will be performed at the last study visit.

This study will assess if it is possible to organize a large clinical trial comparing the use of long-term vs. shorter-term heart monitoring. The investigators will evaluate 24 patients, between the 3 centers, in the same way, the investigators plan to evaluate a larger number of participants (\>1000) in a future study. This will allow us to learn if such a study is possible, identify potential implementation challenges, and develop strategies to overcome those difficulties.

Eligibility criteria: Inclusion Criteria:

- Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke

Exclusion Criteria:

* AF on 24-h inpatient or Holter monitoring
* Atrial or ventricular thrombus
* Other major-risk cardioembolic sources (e.g., mechanical valve)
* Other indications (e.g., venous thromboembolism) or contraindications for OACs.

Primary outcomes:
measure: Number of patients enrolled at in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Screened, declined and dropouts.
timeFrame: 2 years
measure: Number of clinical endpoint events per diagnostic arm
timeFrame: 2 years
measure: Quality of life survey analysis
timeFrame: 2 years
measure: AF timing of diagnosis
timeFrame: 2 years
measure: AF burden (1)
timeFrame: 2 years
measure: AF burden (2)
timeFrame: 2 years
measure: AF burden (3)
timeFrame: 2 years
measure: AF burden (4)
timeFrame: 2 years
measure: AF burden (5)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: LHSC - Western University
name: Luciano A Sposato, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: