Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial

Søren Zöga Diederichsen; Ketil Jørgen Haugan; Lars Køber; Søren Højberg; Axel Brandes; Christian Kronborg; Claus Graff; Anders Gaarsdal Holst; Jonas Bille Nielsen; Derk Krieger; Jesper Hastrup Svendsen

doi:10.1016/j.ahj.2017.02.017

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial

Søren Zöga Diederichsen, Ketil Jørgen Haugan, Lars Køber, Søren Højberg, Axel Brandes, Christian Kronborg, Claus Graff, Anders Gaarsdal Holst, Jonas Bille Nielsen, Derk Krieger, Jesper Hastrup Svendsen

Institut for Klinisk Medicin

30 Citationer (Scopus)

Abstract

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.

Originalsprog	Engelsk
Tidsskrift	American Heart Journal
Vol/bind	187
Sider (fra-til)	122-132
Antal sider	11
ISSN	0002-8703
DOI	https://doi.org/10.1016/j.ahj.2017.02.017
Status	Udgivet - 1 maj 2017

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10.1016/j.ahj.2017.02.017

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Citationsformater

Diederichsen, S. Z., Haugan, K. J., Køber, L., Højberg, S., Brandes, A., Kronborg, C., Graff, C., Holst, A. G., Nielsen, J. B., Krieger, D., & Svendsen, J. H. (2017). Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial. American Heart Journal, 187, 122-132. https://doi.org/10.1016/j.ahj.2017.02.017

Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study) : Rationale and design of a large randomized controlled trial. / Diederichsen, Søren Zöga; Haugan, Ketil Jørgen; Køber, Lars et al.

I: American Heart Journal, Bind 187, 01.05.2017, s. 122-132.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Diederichsen, SZ, Haugan, KJ, Køber, L, Højberg, S, Brandes, A, Kronborg, C, Graff, C, Holst, AG, Nielsen, JB, Krieger, D & Svendsen, JH 2017, 'Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial', American Heart Journal, bind 187, s. 122-132. https://doi.org/10.1016/j.ahj.2017.02.017

Diederichsen SZ, Haugan KJ, Køber L, Højberg S, Brandes A, Kronborg C et al. Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial. American Heart Journal. 2017 maj 1;187:122-132. doi: 10.1016/j.ahj.2017.02.017

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title = "Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial",

abstract = "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.",

keywords = "Aged, Aged, 80 and over, Atrial Fibrillation, Cognition Disorders, Cost-Benefit Analysis, Electrocardiography, Ambulatory, Female, Humans, Male, Quality of Life, Research Design, Risk Factors, Stroke, Journal Article, Multicenter Study, Randomized Controlled Trial",

author = "Diederichsen, {S{\o}ren Z{\"o}ga} and Haugan, {Ketil J{\o}rgen} and Lars K{\o}ber and S{\o}ren H{\o}jberg and Axel Brandes and Christian Kronborg and Claus Graff and Holst, {Anders Gaarsdal} and Nielsen, {Jonas Bille} and Derk Krieger and Svendsen, {Jesper Hastrup}",

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month = may,

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doi = "10.1016/j.ahj.2017.02.017",

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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

PY - 2017/5/1

Y1 - 2017/5/1

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.

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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

SN - 0002-8703

VL - 187

SP - 122

EP - 132

JO - American Heart Journal

JF - American Heart Journal

ER -