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 - 27/09/17
Background |
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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| RCT No. NCT02036450 |
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| Funding: Research grants have been obtained from the Innovation Fund Denmark (DKK 15.6 mio in 2012, Grant No. 12-135225), the Research Foundation for the Capital Region of Denmark (DKK 2.0 mio in 2013, no grant number), the Danish Heart Foundation (DKK 150.000 in 2011, Grant No. 11-04-R83-A3363-22625), Aalborg University Talent Management Programme (DKK 3.0 mio in 2016, no grant number), and the Arvid Nilsson Foundation (DKK 5.0 mio total in 2014 and 2016, no grant numbers). Medtronic Bakken Research Center B.V. has donated an unrestricted research grant to the study of 900 of the implantable loop recorders and a grant to cover salary for one research nurse for 1 year at each of the centers (DKK 1.9 mio in 2014, no grant number). |
Vol 187
P. 122-132 - mai 2017 Retour au numéro
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