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Sökning: WFRF:(Ström Eva) > (2020-2024) > Multicentre, nation...

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding : the AF SPICE protocol

Engdahl, Johan (författare)
Karolinska Institutet,Danderyd Hospital,Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.
Straat, Kajsa (författare)
Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden
Isaksson, Eva (författare)
Karolinska Institutet,Danderyd Hospital,Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.
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Rooth, Elisabeth (författare)
Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden
Svennberg, Emma (författare)
Karolinska Institutet,Karolinska University Hospital,Karolinska Univ Hosp, Dept Med, Karolinska Inst, Stockholm, Sweden.
Norrving, Bo (författare)
Lund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Klinisk strokeforskning,Forskargrupper vid Lunds universitet,Stroke policy och kvalitetsregisterforskning,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Stroke Research Group,Lund University Research Groups,Stroke policy and quality register research,Lund Univ, Neurol Sect, Dept Clin Sci, Lund, Sweden.
von Euler, Mia, 1967- (författare)
Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,School of Medicine, Department of Neurology, Örebro Universitet, Örebro, Örebro, Sweden,Örebro Univ, Sch Med, Dept Neurol, Örebro, Sweden.
Hellqvist, Kjersti (författare)
Alingsas lasarett, Dept Med, Alingsas, Sweden.,Department of Medicine, Alingsas lasarett, Alingsas, Sweden
Gu, Weigang (författare)
Karolinska Inst, South Hosp, Dept Clin Sci, Stockholm, Sweden.,Department of Clinical Sciences, South Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden,Stockholm South General Hospital
Ström, Jakob O., 1983- (författare)
Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,School of Medicine, Department of Neurology, Örebro Universitet, Örebro, Örebro, Sweden,Örebro Univ, Sch Med, Dept Neurol, Örebro, Sweden.
Själander, Sara, 1981- (författare)
Umeå University,Umeå universitet,Institutionen för folkhälsa och klinisk medicin,Umeå Univ, Dept Publ Hlth & Clin Med, Umeå, Sweden.
Eriksson, Marie, Professor (författare)
Umeå universitet,Statistik,Umeå Univ, Dept Stat, USBE, Umeå, Sweden.
Åsberg, Signild, 1972- (författare)
Uppsala University,Uppsala universitet,Klinisk epidemiologi,Neurologi,Department of Medical Sciences, Uppsala University, Uppsala, Sweden
Wester, Per, 1959- (författare)
Umeå University,Umeå universitet,Institutionen för folkhälsa och klinisk medicin,Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Stockholm, Sweden,Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Stockholm, Sweden.;Umeå Univ, Dept Publ Hlth & Clin Med, Umeå, Sweden.
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 (creator_code:org_t)
BMJ Publishing Group Ltd, 2023
2023
Engelska.
Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:11
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Introduction: Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.Methods and analysis: AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥ 70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24-72hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023-2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.Ethics and dissemination: Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021-02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice. Trial registration number NCT05134454.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)

Nyckelord

Stroke
Cardiology
Thromboembolism
Cardiology
Stroke
Thromboembolism

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