The ImPact of Trimetazidine on MicrOcirculation After Stenting for Stable Coronary Artery Disease (PATMOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02107144|
Recruitment Status : Unknown
Verified March 2016 by Ivan Ilic, Clinical Hospital Center Zemun.
Recruitment status was: Recruiting
First Posted : April 8, 2014
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Microcirculation Vascular Resistance||Drug: trimetazidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||The Study to Assess the Effect of Trimetazidine on Index of Microcirculatory Resistance (IMR), Measured by Coronary Pressure and Temperature Wire, in Patients With Stable Coronary Artery Disease|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2016|
Patients, who are trimetazidine (TMZ) naïve, will be randomly assigned to receive trimetazidine plus previous medications (TMZ group) 48h before scheduled PCI- Paients that are TMZ naïve and randomized to TMZ group will be given oral loading of 70mg TMZ.
After being randomized to Trimetazidin and cardiac medication vs. only cardiac medication, patient will undergo scheduled PCI of single, new, native coronary artery lesion using balloon predilatation and subsequent stenting.
No Intervention: Control
Patients, who are TMZ naïve, will be randomly assigned to receive just previous cardiac medication (Control group).
- index of microcirculatory resistance [ Time Frame: On day 2 during percutaneous coronary intervention ]Trimetazidine given on day 0 before elective percutaneous coronary intervention would decrease microvascular dysfunction by reducing index of microcirculatory resistance (IMR) measured by thermodilution method using coronary pressure and temperature wire on day 2 during PCI
- periprocedural myocardial necrosis [ Time Frame: on day 2 after PCI ]Periprocedural myocardial necrosis will be measured by collecting blood samples for Troponin I, CK and CK-MB at 6, 12 and 24 h after the procedure.
- change in 2D myocardial strain [ Time Frame: on day 2 30 minutes after completion of PCI procedure ]Comprehensive echocardiogram with 2D-strain analysis will be done before and immediately after PCI procedure to correlate change in IMR with possible change in 2D strain after PCI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107144
|Clinical Hospital Center Zemun||Recruiting|
|Belgrade, Serbia, 11080|
|Contact: Ivan Ilic, MD +381641374455 email@example.com|
|Contact: Gojko Obradovic, MD +381641391139 firstname.lastname@example.org|
|Sub-Investigator: Miliovoje Cerovic, MD|
|Principal Investigator: Aleksandar N Neskovic, MD, PhD|
|Sub-Investigator: Srdjan Kafedzic, MD|
|Study Director:||Aleksandar N Neskovic, MD, PhD||Clinical Hospital Center Zemun|