"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)"

NCT01025947 | Unknown

• 1 other identifier: HCUV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

STUDY TYPE: Prospective, national , multicenter, and observational study. OBJECTIVE: To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years. DEVICE: Reveal XT 9529 (SQDM) SAMPLE SIZE AND STUDY DURATION: 100 patients enrolled which will be followed during a period of 2 years.

Conditions

Atrial Fibrillation; Stroke

Keywords

Atrial fibrillation; Cryptogenic stroke; Implantable loop recorder

Outcome Measures

Primary Outcomes (1)

• First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.

  Patients will be followed up during two years, regardless of reaching or not the primary endpoint.

Secondary Outcomes (4)

• All subsequent AF episodes detected by the ILR after primary outcome (AF burden)

  Patients will be followed up during two years

• AF episodes detected by external monitoring

  Patients will be followed up during two years

• Presence of stroke, recurrent TIA, or silent infarction in neuroimaging

  Patients will be followed up during two years

• Changes in anticoagulant therapy

  Patients will be followed up during two years

Study Arms (1)

Study group

Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation

You may qualify if:

• All patients included must meet one of these two conditions:
• Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
• First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
• All patients must meet all of the following:
• The patient has been implanted an ILR within 30 days after qualifying event
• Age between 45-85 years
• No stenosis \>50% in any arterial vessel corresponding to the affected territory
• Normal Echocardiography
• Normal 24 hours EKG Holter recording
• Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
• Acceptance and signature of Patient Informed Consent.

You may not qualify if:

• All patients included cannot meet any of the following conditions:
• Recurrent stroke or TIA
• Stroke or TIA with determined etiology according to TOAST criteria.
• Anticoagulation indication at the time of enrollment in the study.
• Total contraindication for anticoagulation therapy
• Atrial fibrillation detection prior to enrollment
• Severe cognitive impairment or dementia
• Patient unable to be followed up
• Patients enrolled in another clinical trial
• Patients with life expectancy of less than 1 year
• Pregnancy

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Universidad de Murcia: collaborator

Study Sites (2)

Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Related Publications (9)

• Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available.

  PMID: 17194875 BACKGROUND

• Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.

  PMID: 17190894 BACKGROUND

• Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.

  PMID: 7678184 BACKGROUND

• Adams HP Jr, Davis PH, Leira EC, Chang KC, Bendixen BH, Clarke WR, Woolson RF, Hansen MD. Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology. 1999 Jul 13;53(1):126-31. doi: 10.1212/wnl.53.1.126.

  PMID: 10408548 BACKGROUND

• Sacco RL, Ellenberg JH, Mohr JP, Tatemichi TK, Hier DB, Price TR, Wolf PA. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. 1989 Apr;25(4):382-90. doi: 10.1002/ana.410250410.

  PMID: 2712533 BACKGROUND

• Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. 2004 Jul;35(7):1647-51. doi: 10.1161/01.STR.0000131269.69502.d9. Epub 2004 May 20.

  PMID: 15155965 BACKGROUND

• Douen AG, Pageau N, Medic S. Serial electrocardiographic assessments significantly improve detection of atrial fibrillation 2.6-fold in patients with acute stroke. Stroke. 2008 Feb;39(2):480-2. doi: 10.1161/STROKEAHA.107.492595. Epub 2008 Jan 3.

  PMID: 18174488 BACKGROUND

• Liao J, Khalid Z, Scallan C, Morillo C, O'Donnell M. Noninvasive cardiac monitoring for detecting paroxysmal atrial fibrillation or flutter after acute ischemic stroke: a systematic review. Stroke. 2007 Nov;38(11):2935-40. doi: 10.1161/STROKEAHA.106.478685. Epub 2007 Sep 27.

  PMID: 17901394 BACKGROUND

• Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9. doi: 10.1016/j.ehj.2004.05.013.

  PMID: 15231369 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Ricardo Ruiz-Granell, MD, Phd

  Hospital Clinico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

• Arcadio Garcia-Alberola, MD, PhD

  Hospital Universitario Virgen de la Arrixaca

  STUDY CHAIR

• Ana Morales, MD

  Hospital Universitario Virgen de la Arrixaca

  STUDY CHAIR

• Alejandro Ponz, MD

  Hospital Clinico Universitario de Valencia

  STUDY CHAIR

Central Study Contacts

Ricardo Ruiz-Granell, MD, PhD

CONTACT

0034 963862658; ruiz_ric@gva.es

Arcadio García-Alberola, MD, PhD

CONTACT

arcadi@secardiologia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 28, 2010

Record last verified: 2010-06

Locations

ES (2)