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

Department of Clinical Medicine

30 Citations (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.

Original language	English
Journal	American Heart Journal
Volume	187
Pages (from-to)	122-132
Number of pages	11
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2017.02.017
Publication status	Published - 1 May 2017

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

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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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.

In: American Heart Journal, Vol. 187, 01.05.2017, p. 122-132.

Research output: Contribution to journal › Journal article › Research › 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, vol. 187, pp. 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 May 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.",

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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

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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 - Quality of Life

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