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Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
prolonged ECG monitoring
standard care
Sponsored by
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring ischemic stroke, ECG monitoring, atrial fibrillation (/flutter)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
  • Stroke symptoms started ≤ 7 days ago.
  • Age ≥ 60 years.
  • Modified Rankin scale ≤ 2 (prior to index event).

Exclusion Criteria:

  • Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
  • Indication for oral anticoagulation at randomisation.
  • Absolute contra-indication against oral anticoagulation at randomisation.
  • Intracerebral bleeding in medical history.
  • Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.
  • Significant carotid artery or vertebral artery stenosis > 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
  • Implanted pacemaker device or cardioverter/defibrillator.
  • Life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer).
  • Concomitant participation in other controlled randomised trial.

Sites / Locations

  • Dept. of Cardiology and Pneumology, University Medical Center Goettingen
  • Clinic and Policlinic for Neurology, University of Mainz
  • Dept. of Neurology, Nordwest-Hospital Sanderbusch
  • Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

prolonged ECG monitoring

standard care

Arm Description

Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6

Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Outcomes

Primary Outcome Measures

number of atrial fibrillation/flutter
The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group.

Secondary Outcome Measures

number of atrial fibrillation (/flutter) within 12 months after patient's inclusion
Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
number of atrial fibrillation (/flutter) without hospitalisation
Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring.
number of recurrent stroke or systemic embolism
Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
total mortality
Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
number of cardiovascular deaths
number of cerebrovascular deaths
number of transient ischemic attacks
number of myocardial infarctions
number of bleeding complications
quality of life
number of atrial fibrillation (/flutter) in extended monitoring period
Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.
costs
number of correct monitorings
To assess the feasibility of monitoring procedures.

Full Information

First Posted
May 7, 2013
Last Updated
April 30, 2020
Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01855035
Brief Title
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
Official Title
A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
ischemic stroke, ECG monitoring, atrial fibrillation (/flutter)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prolonged ECG monitoring
Arm Type
Experimental
Arm Description
Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
Arm Title
standard care
Arm Type
Other
Arm Description
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Intervention Type
Other
Intervention Name(s)
prolonged ECG monitoring
Intervention Description
10-day Holter ECG measurement
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Primary Outcome Measure Information:
Title
number of atrial fibrillation/flutter
Description
The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group.
Time Frame
30 month after study start
Secondary Outcome Measure Information:
Title
number of atrial fibrillation (/flutter) within 12 months after patient's inclusion
Description
Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
Time Frame
24 months after study start
Title
number of atrial fibrillation (/flutter) without hospitalisation
Description
Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring.
Time Frame
30 months after study start
Title
number of recurrent stroke or systemic embolism
Description
Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
Time Frame
24 months after study start
Title
total mortality
Description
Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
Time Frame
24 months after study start
Title
number of cardiovascular deaths
Time Frame
24 months after study start
Title
number of cerebrovascular deaths
Time Frame
24 months after study start
Title
number of transient ischemic attacks
Time Frame
24 months after study start
Title
number of myocardial infarctions
Time Frame
24 months after study start
Title
number of bleeding complications
Time Frame
24 months after study start
Title
quality of life
Time Frame
24 months after study start
Title
number of atrial fibrillation (/flutter) in extended monitoring period
Description
Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.
Time Frame
24 months after study start
Title
costs
Time Frame
24 months after study start
Title
number of correct monitorings
Description
To assess the feasibility of monitoring procedures.
Time Frame
24 months after study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging. Stroke symptoms started ≤ 7 days ago. Age ≥ 60 years. Modified Rankin scale ≤ 2 (prior to index event). Exclusion Criteria: Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG. Indication for oral anticoagulation at randomisation. Absolute contra-indication against oral anticoagulation at randomisation. Intracerebral bleeding in medical history. Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours. Significant carotid artery or vertebral artery stenosis > 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms. Implanted pacemaker device or cardioverter/defibrillator. Life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer). Concomitant participation in other controlled randomised trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Wachter, PD Dr. med.
Organizational Affiliation
Dept. of Cardiology and Pneumology, University Medical Center Goettingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Klaus Gröschel, PD Dr.med.
Organizational Affiliation
Clinic and Policlinic for Neurology, University of Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Cardiology and Pneumology, University Medical Center Goettingen
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Clinic and Policlinic for Neurology, University of Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Dept. of Neurology, Nordwest-Hospital Sanderbusch
City
Sande
ZIP/Postal Code
26452
Country
Germany
Facility Name
Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28187920
Citation
Wachter R, Groschel K, Gelbrich G, Hamann GF, Kermer P, Liman J, Seegers J, Wasser K, Schulte A, Jurries F, Messerschmid A, Behnke N, Groschel S, Uphaus T, Grings A, Ibis T, Klimpe S, Wagner-Heck M, Arnold M, Protsenko E, Heuschmann PU, Conen D, Weber-Kruger M; Find-AF(randomised) Investigators and Coordinators. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): an open-label randomised controlled trial. Lancet Neurol. 2017 Apr;16(4):282-290. doi: 10.1016/S1474-4422(17)30002-9. Epub 2017 Feb 8. Erratum In: Lancet Neurol. 2017 Apr;16(4):261.
Results Reference
background
PubMed Identifier
25262252
Citation
Weber-Kruger M, Gelbrich G, Stahrenberg R, Liman J, Kermer P, Hamann GF, Seegers J, Groschel K, Wachter R; Find-AF(RANDOMISED) investigators. Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring--Find-AF(RANDOMISED) --rationale and design. Am Heart J. 2014 Oct;168(4):438-445.e1. doi: 10.1016/j.ahj.2014.06.018. Epub 2014 Jul 3.
Results Reference
background
PubMed Identifier
33421630
Citation
Sadlonova M, Wasser K, Nagel J, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Groschel K, Herrmann-Lingen C, Wachter R. Health-related quality of life, anxiety and depression up to 12 months post-stroke: Influence of sex, age, stroke severity and atrial fibrillation - A longitudinal subanalysis of the Find-AFRANDOMISED trial. J Psychosom Res. 2021 Mar;142:110353. doi: 10.1016/j.jpsychores.2020.110353. Epub 2021 Jan 2.
Results Reference
derived
PubMed Identifier
31813354
Citation
Wasser K, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Seegers J, Binder L, Gelbrich G, Groschel K, Wachter R. Brain Natriuretic Peptide and Discovery of Atrial Fibrillation After Stroke: A Subanalysis of the Find-AFRANDOMISED Trial. Stroke. 2020 Feb;51(2):395-401. doi: 10.1161/STROKEAHA.119.026496. Epub 2019 Dec 9.
Results Reference
derived
PubMed Identifier
31071137
Citation
Wasser K, Weber-Kruger M, Jurries F, Liman J, Hamann GF, Kermer P, Uphaus T, Protsenko E, Seegers J, Mende M, Groschel K, Wachter R. The cardiac diagnostic work-up in stroke patients-A subanalysis of the Find-AFRANDOMISED trial. PLoS One. 2019 May 9;14(5):e0216530. doi: 10.1371/journal.pone.0216530. eCollection 2019.
Results Reference
derived

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Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

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