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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03540459
Other study ID # Les Grands Prés
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date September 30, 2020

Study information

Verified date February 2020
Source Les Grands Prés
Contact philippe meurin, MD
Phone +33674003218
Email philippemeurin@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy


Description:

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy the main objective of the study will be to look for central sleep apnea


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 30, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome

Exclusion Criteria:

- left ventricular ejection fraction < 50%

- patients refusal

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
sleep polygraphy
sleep polygraphy (one night) in all included patients

Locations

Country Name City State
France Les Grands Prés Villeneuve Saint Denis

Sponsors (1)

Lead Sponsor Collaborator
Les Grands Prés

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary central apnea index mean central apnea index: apnea hypopnea index (AHI) is the scale commonly used to assess sleep disordered breathing.This scale includes central and obstructive apnea and hypopnea. The main outcome will be the central apnea index: number of central apnea per hour at baseline
Secondary global apnea hypopnea index number of apnea and hypopnea per our baseline
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