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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03166969
Other study ID # P14/08_HOLTER 21J
Secondary ID
Status Completed
Phase N/A
First received September 12, 2016
Last updated May 23, 2017
Start date February 2007
Est. completion date January 2013

Study information

Verified date May 2017
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Retrospective study, single-center, on 171 patients, presented a cryptogenic TIA and Minor stroke.

This study objective is to determine profitability of Holter 21 days for screening paroxystic ACFA / flutter in cryptogenic TIA/Minor stroke, and identify the predictive factors of discovery a paroxystic ACFA on Holter 21 days. Clinical and échocardiographics factors, and brain imaging (scanner and MRI) will be analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cryptogenic TIA/Minor stroke

- Age > 18 years

- Medical care in Neuro Vascular Unit of CH Versailles

- Holter 21 days performed

Exclusion Criteria:

1. ACFA history

2. ECG or telemetry who showed ACFA before the Holter initializing

3. Carotid Stenosis / symptomatic vertebral

4. Arterial dissection

5. Prothrombotic state demonstrated by laboratory tests

6. Infective endocarditis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Holter 21 days


Locations

Country Name City State
France Centre Hospitalier de Versailles Le Chesnay

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Sudacevschi V, Bertrand C, Chadenat ML, Tarnaud C, Pico F. Predictors of Occult Atrial Fibrillation in One Hundred Seventy-One Patients with Cryptogenic Transient Ischemic Attack and Minor Stroke. J Stroke Cerebrovasc Dis. 2016 Nov;25(11):2673-2677. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of atrial fibrillation detected on long duration ( 21 days) cardiac rythm holter monitoring Atrial fibrillation >= 30 secondes Day 21