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

Stroke Clinical Trial

— CRYPTONITE  

Official title:

Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01025947
• Other study ID #: HCUV
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2009
• Last updated: June 25, 2010
• Start date: March 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2010
• Source: University of Valencia
• Contact: Ricardo Ruiz-Granell, MD, PhD
• Phone: 0034 963862658
• Email: ruiz_ric[@]gva.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Description:

Observational study in patients with cryptogenic stroke (TOAST criteria) and with an implanted EKG loop recorder, with the primary objective of knowing the atrial fibrillation incidence in this population

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Clinico Universitario de Valencia	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Hospital Universitario Virgen de la Arrixaca, Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 May 20. — View Citation

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. Epub 2007 Sep 27. Review. — View Citation

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. Epub 2006 Dec 28. Erratum in: Circulation. 2007 Feb 6;115(5):e172. Circulation. 2010 Jul 6;122(1):e9. Kissela, Bret [corrected to Kissela, Brett]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	All subsequent AF episodes detected by the ILR after primary outcome (AF burden)		Patients will be followed up during two years	No
Secondary	AF episodes detected by external monitoring		Patients will be followed up during two years	No
Secondary	Presence of stroke, recurrent TIA, or silent infarction in neuroimaging		Patients will be followed up during two years	No
Secondary	Changes in anticoagulant therapy		Patients will be followed up during two years	No