Søren Zöga Diederichsen1, Ketil Jørgen Haugan2, Lars Køber3, Søren Højberg4, Axel Brandes5, Christian Kronborg6, Claus Graff7, Anders Gaarsdal Holst8, Jonas Bille Nielsen9, Derk Krieger10, Jesper Hastrup Svendsen11. 1. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 2. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark. 3. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. 4. Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg, Denmark. 5. Department of Cardiology, Odense University Hospital, and Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 6. Centre of Health Economics Research (COHERE), Department of Business and Economics, University of Southern Denmark, Odense, Denmark. 7. Department of Health Science and Technology, Aalborg University, Aalborg, Denmark. 8. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; The Danish National Research Foundation Center for Cardiac Arrhythmia, Copenhagen, Denmark. 9. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI. 10. University Hospital Zurich, Switzerland; Mediclinic City Hospital, Dubai, United Arabic Emirates. 11. 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.
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.
RCT Entities:
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.
Authors: Anne Simone Juhl Christiansen; Marie Louise Sletskov Møller; Christian Kronborg; Ketil Jørgen Haugan; Lars Køber; Søren Højberg; Axel Brandes; Claus Graff; Søren Zöga Diederichsen; Jonas Bille Nielsen; Derk Krieger; Anders Gaarsdal Holst; Jesper Hastrup Svendsen Journal: Eur J Health Econ Date: 2021-03-18
Authors: Flemming Javier Olsen; Søren Zöga Diederichsen; Peter Godsk Jørgensen; Magnus T Jensen; Anders Dahl; Nino Emmanuel Landler; Claus Graff; Axel Brandes; Derk Krieger; Ketil Haugan; Lars Køber; Søren Højberg; Jesper Hastrup Svendsen; Tor Biering-Sørensen Journal: PLoS One Date: 2022-06-03 Impact factor: 3.752
Authors: Emelia J Benjamin; Alan S Go; Patrice Desvigne-Nickens; Christopher D Anderson; Barbara Casadei; Lin Y Chen; Harry J G M Crijns; Ben Freedman; Mellanie True Hills; Jeff S Healey; Hooman Kamel; Dong-Yun Kim; Mark S Link; Renato D Lopes; Steven A Lubitz; David D McManus; Peter A Noseworthy; Marco V Perez; Jonathan P Piccini; Renate B Schnabel; Daniel E Singer; Robert G Tieleman; Mintu P Turakhia; Isabelle C Van Gelder; Lawton S Cooper; Sana M Al-Khatib Journal: Circulation Date: 2021-01-25 Impact factor: 29.690
Authors: Gelu Simu; Radu Rosu; Gabriel Cismaru; Mihai Puiu; Gabriel Gusetu; Ioan Minciuna; Sabina Istratoaie; Raluca Tomoaia; Dumitru Zdrenghea; Dana Pop Journal: Cardiovasc J Afr Date: 2021-01-15 Impact factor: 0.802