Journal article
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 SZ Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
- Haugan KJ Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
- Køber L Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
- Højberg S Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg, Denmark.
- Brandes A Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
- Kronborg C Centre of Health Economics Research (COHERE), Department of Business and Economics, University of Southern Denmark, Odense, Denmark.
- Graff C Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
- Holst AG Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; The Danish National Research Foundation Center for Cardiac Arrhythmia, Copenhagen, Denmark.
- Nielsen JB Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.
- Krieger D University Hospital Zurich, Switzerland; Mediclinic City Hospital, Dubai, United Arabic Emirates.
- Svendsen JH Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; The Danish National Research Foundation Center for Cardiac Arrhythmia, Copenhagen, Denmark. Electronic address: Jesper.Hastrup.Svendsen@regionh.dk.
- 2017-04-30
Published in:
- American heart journal. - 2017
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
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.ahj.2017.02.017
- PMID 28454796
- Persistent URL
- https://sonar.ch/global/documents/260678
Statistics
Document views: 7
File downloads: