Last updated: April 17, 2024
Sponsor: Servier Russia
Overall Status: Completed
Phase
N/A
Condition
Angina
Thrombosis
Coronary Artery Disease
Treatment
speckle tracking mode of the stress ECHO test with dobutamine
Clinical Study ID
NCT05210465
IC4-06795-067-RUS
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age older than 18 yearsAge older than 18 years
- Signed informed consent form
- Stable angina pectoris (CCS I-III FC) with signs of myocardial ischemia despitetreatment with antianginal drug(s) present either clinically and/ or at stress ECHOtest with dobutamine
- History of myocardial infraction occurred 6 months and more from the inclusion date
- Trimetazidine (TMZ) is recommended as add on to the current antianginal treatment andthis recommendation precedes inclusion of a patient in the study
- Intention to perform a stress echo with spackle tracking precedes the start of TMZ
- Physician's intention to perform a stress ECHO test within a 6-month period after thedate of inclusion in the study
Exclusion
Exclusion Criteria:
- Age over 75 years or under 18 years old
- Hypersensitivity to the active substance or any excipient specified in SmPc of TMZ 80mg OD
- Parkinson's disease, parkinsonism symptoms, tremors, restless legs syndrome and otheraccompanying movement disorders
- Known severe or moderate renal impairment (creatinine clearance <60 ml / min).
- Angina pectoris of IV functional CCS class
- Heart failure IV functional class by NYHA
- Cardiac valves insufficiency with regurgitation of stage III and higher
- Myocardial infarction less than 6 months from the inclusion date
- Acute cerebrovascular event (stroke of various origins, transient ischemic attack)within 6 months before screening date
- Uncontrolled arterial hypertension of stage 3 (blood pressure above 180/100 mm Hg)despite ongoing antihypertensive therapy
- Fructose / sucrose intolerance, presence of glucose-galactose malabsorption syndrome,sucrose-somaltase deficiency and other enzymopathies associated with intolerance tosucrose, which is part of the drug
- Pregnancy, breastfeeding
- Any contraindications to stress echocardiography with dobutamine
Study Design
Total Participants: 36
Treatment Group(s): 1
Primary Treatment: speckle tracking mode of the stress ECHO test with dobutamine
Phase:
Study Start date:
March 03, 2022
Estimated Completion Date:
April 17, 2024
Study Description
Connect with a study center
"Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo,
Russian FederationSite Not Available
Barbarash Olga Leonidovna
Moscow,
Russian FederationSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.