TY - JOUR

T1 - Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study)

T2 - Rationale and design of a large randomized controlled trial

AU - Diederichsen, Søren Zöga

AU - Haugan, Ketil Jørgen

AU - Køber, Lars

AU - Højberg, Søren

AU - Brandes, Axel

AU - Kronborg, Christian

AU - Graff, Claus

AU - Holst, Anders Gaarsdal

AU - Nielsen, Jonas Bille

AU - Krieger, Derk

AU - Svendsen, Jesper Hastrup

N1 - Copyright © 2017 Elsevier Inc. All rights reserved.

PY - 2017/5

Y1 - 2017/5

N2 - Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention.METHODS: The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death.CONCLUSION: The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention.

AB - Atrial fibrillation (AF) increases the rate of stroke 5-fold, and AF-related strokes have a poorer prognosis compared with non-AF-related strokes. Atrial fibrillation and stroke constitute an intensifying challenge, and health care organizations are calling for awareness on the topic. Previous studies have demonstrated that AF is often asymptomatic and consequently undiagnosed. The implantable loop recorder (ILR) allows for continuous, long-term electrocardiographic monitoring with daily transmission of arrhythmia information, potentially leading to improvement in AF detection and stroke prevention.METHODS: The LOOP study is an investigator-initiated, randomized controlled trial with 6,000 participants randomized 3:1 to a control group or to receive an ILR with continuous electrocardiographic monitoring. Participants are identified from Danish registries and are eligible for inclusion if 70years or older and previously diagnosed as having at least one of the following conditions: hypertension, diabetes mellitus, heart failure, or previous stroke. Exclusion criteria include history of AF and current oral anticoagulation treatment. When an AF episode lasting ≥6minutes is detected, oral anticoagulation will be initiated according to guidelines. Expected follow-up is 4years. The primary end point is time to stroke or systemic embolism, whereas secondary end points include time to AF diagnosis and death.CONCLUSION: The LOOP study will evaluate health benefits and cost-effectiveness of ILR as a screening tool for AF to prevent stroke in patients at risk. Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention.

KW - Aged

KW - Aged, 80 and over

KW - Atrial Fibrillation

KW - Cognition Disorders

KW - Cost-Benefit Analysis

KW - Electrocardiography, Ambulatory

KW - Female

KW - Humans

KW - Male

KW - Quality of Life

KW - Research Design

KW - Risk Factors

KW - Stroke

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.1016/j.ahj.2017.02.017

DO - 10.1016/j.ahj.2017.02.017

M3 - Journal article

C2 - 28454796

VL - 187

SP - 122

EP - 132

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -