Prediction of AF in ESUS

NCT02766205 | Unknown DMC

• 1 other identifier: WI211961
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim of the proposed study is to identify predictors of covert atrial fibrillation (AF) in Embolic Stroke of Undetermined Source (ESUS) patients and develop a prognostic score for the identification of covert AF in this population.

Conditions

Embolic Stroke of Undetermined Source

Keywords

Embolic Stroke of Undetermined Source; Atrial fibrillation; prognostic score

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Occurrence of atrial fibrillation during follow-up assessed either by 12-lead electrocardiogram (ECG) or telemetry or 24-hours Holter ECG, or longer-term ECG monitoring.

  Twelve months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The dataset will be derived mainly from three high quality, prospective stroke registries: the Acute STroke Registry and Analysis of Lausanne (ASTRAL), the Athens Stroke Registry and the Larissa Stroke Outcome Registry (LASTRO)

You may qualify if:

• \. Embolic stroke of undetermined source (ESUS) defined as:
• Ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain CT or MRI that is not lacunar (i.e., subcortical infarct ≤1.5 cm), and
• Absence of cervical carotid atherosclerotic stenosis (or vertebral and basilar artery stenosis in case of posterior circulation stroke), that is ≥ 50%, or occlusion in arteries supplying the area of ischemia in CT or magnetic resonance (MR) angiography or ultrasound, and
• No history of AF, no documented AF on 12-lead electrocardiogram (ECG) or episode of AF lasting 6 minutes or longer detected after ≥ 24-hour cardiac rhythm monitoring (Holter or telemetry), and
• No intra-cardiac thrombus on transthoracic echocardiography, and
• No other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)
• \. Age ≥18 years
• \. Written informed consent

You may not qualify if:

• \. ≥ 50% luminal stenosis or occlusion in arteries supplying the area of ischemia
• \. History of AF
• \. Life expectancy less than 6 months

Sponsors & Collaborators

• University of Thessaly: lead
• University of Lausanne: collaborator
• University of Athens: collaborator

Study Sites (3)

Department of Clinical Therapeutics, University of Athens, Alexandra Hospital

Athens, Greece

Location

Medical School, University of Thessaly, Larissa University Hospital

Larissa, 41110, Greece

Location

Centre Cérébrovasculaire, Service de Neurologie, Département des Neurosciences Cliniques, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Lausanne, Switzerland

Location

Related Publications (11)

• Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.

  PMID: 24646875 BACKGROUND

• Ntaios G, Papavasileiou V, Milionis H, Makaritsis K, Vemmou A, Koroboki E, Manios E, Spengos K, Michel P, Vemmos K. Embolic Strokes of Undetermined Source in the Athens Stroke Registry: An Outcome Analysis. Stroke. 2015 Aug;46(8):2087-93. doi: 10.1161/STROKEAHA.115.009334. Epub 2015 Jul 9.

  PMID: 26159795 BACKGROUND

• Ntaios G, Papavasileiou V, Milionis H, Makaritsis K, Manios E, Spengos K, Michel P, Vemmos K. Embolic strokes of undetermined source in the Athens stroke registry: a descriptive analysis. Stroke. 2015 Jan;46(1):176-81. doi: 10.1161/STROKEAHA.114.007240. Epub 2014 Nov 6.

  PMID: 25378429 BACKGROUND

• Diener HC, Easton JD, Granger CB, Cronin L, Duffy C, Cotton D, Brueckmann M, Sacco RL; RE-SPECT ESUS Investigators. Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS). Int J Stroke. 2015 Dec;10(8):1309-12. doi: 10.1111/ijs.12630. Epub 2015 Sep 30.

  PMID: 26420134 BACKGROUND

• Kitsiou A, Sagris D, Schabitz WR, Ntaios G. Validation of the AF-ESUS score to identify patients with embolic stroke of undetermined source and low risk of device-detected atrial fibrillation. Eur J Intern Med. 2021 Jul;89:135-136. doi: 10.1016/j.ejim.2021.04.003. Epub 2021 May 2. No abstract available.

  PMID: 33952425 DERIVED

• Ntaios G, Weng SF, Perlepe K, Akyea R, Condon L, Lambrou D, Sirimarco G, Strambo D, Eskandari A, Karagkiozi E, Vemmou A, Korompoki E, Manios E, Makaritsis K, Vemmos K, Michel P. Data-driven machine-learning analysis of potential embolic sources in embolic stroke of undetermined source. Eur J Neurol. 2021 Jan;28(1):192-201. doi: 10.1111/ene.14524. Epub 2020 Oct 7.

  PMID: 32918305 DERIVED

• Ntaios G, Perlepe K, Lambrou D, Sirimarco G, Strambo D, Eskandari A, Karagkiozi E, Vemmou A, Korompoki E, Manios E, Makaritsis K, Vemmos K, Michel P. Identification of patients with embolic stroke of undetermined source and low risk of new incident atrial fibrillation: The AF-ESUS score. Int J Stroke. 2021 Jan;16(1):29-38. doi: 10.1177/1747493020925281. Epub 2020 May 19.

  PMID: 32423317 DERIVED

• Leventis I, Perlepe K, Sagris D, Sirimarco G, Strambo D, Georgiopoulos G, Eskandari A, Karagkiozi E, Vemmou A, Koroboki E, Manios E, Makaritsis K, Vemmos K, Michel P, Ntaios G. Characteristics and outcomes of Embolic Stroke of Undetermined Source according to stroke severity. Int J Stroke. 2020 Oct;15(8):866-871. doi: 10.1177/1747493020909546. Epub 2020 Mar 2.

  PMID: 32122289 DERIVED

• Perlepe K, Sirimarco G, Strambo D, Eskandari A, Karagkiozi E, Vemmou A, Koroboki E, Manios E, Makaritsis K, Vemmos K, Michel P, Ntaios G. Left atrial diameter thresholds and new incident atrial fibrillation in embolic stroke of undetermined source. Eur J Intern Med. 2020 May;75:30-34. doi: 10.1016/j.ejim.2020.01.002. Epub 2020 Jan 15.

  PMID: 31952983 DERIVED

• Ntaios G, Perlepe K, Lambrou D, Sirimarco G, Strambo D, Eskandari A, Karagkiozi E, Vemmou A, Koroboki E, Manios E, Makaritsis K, Vemmos K, Michel P. Prevalence and Overlap of Potential Embolic Sources in Patients With Embolic Stroke of Undetermined Source. J Am Heart Assoc. 2019 Aug 6;8(15):e012858. doi: 10.1161/JAHA.119.012858. Epub 2019 Jul 31.

  PMID: 31364451 DERIVED

• Ntaios G, Perlepe K, Sirimarco G, Strambo D, Eskandari A, Karagkiozi E, Vemmou A, Koroboki E, Manios E, Makaritsis K, Michel P, Vemmos K. Carotid plaques and detection of atrial fibrillation in embolic stroke of undetermined source. Neurology. 2019 Jun 4;92(23):e2644-e2652. doi: 10.1212/WNL.0000000000007611. Epub 2019 May 8.

  PMID: 31068479 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• George Ntaios, MD, PhD

  Medical School, University of Thessaly, Larissa University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc (ESO Stroke Medicine), PhD, FESO, Assistant Professor of Internal Medicine, Medical School, University of Thessaly, Larissa University Hospital

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2019
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

CH (1); GR (2)