Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI (MASTARD)

Russian Academy of Medical Sciences (RAMS)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cardiovascular Diseases; Acute Myocardial Infarction; Vascular Diseases

Treatments: Drug: Doxycycline; Other: Standard care for STEMI

Study type: Interventional

Funder types: Other

Identifiers

NCT02562651

1202

Details and patient eligibility

About

The purpose of the study is to investigate the changes of myocardial biomechanics and efficacy of doxycycline in patients with primary anterior STEMI.

Full description

It is known that MMPs (matrix metalloproteinases) take part in myocardial remodeling, which lead to the adverse remodeling of left ventricular. Doxycycline inhibiting MMPs and it help to prevent collagen degradation and following LV (left ventricular) dilatation. Some experimental studies on rat models have suggested an anti-remodeling effect of doxycycline in myocardial infarction by means of decrease in activity of MMPs-2 and recovery of contractile function of myocardium. The clinical trial was performed at 2013 (D.Antoniucci), but it was a single study and confirmed theoretical and experimental background.

The study is randomized, opened, controlled. 45 patients with the first anterior STEMI will be enrolled. On admission all patients will receive reperfusion therapy during the first 24 h. Patients will be randomized by the open envelope method and after that some of the participants will be on doxycycline (100 mg b.i.d. for 7 days) in addition to routine medical therapy for STEMI, but other will be on routine medical therapy of STEMI. After that they will have echocardiography at 3-d, 7-th, 14-th days and 6 month after STEMI. The investigators will evaluate left ventricular function of these patients by routine and speckle-tracking echocardiography, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, also the investigators will take blood samples to assess metalloproteinases (MMPs) and other biomarkers.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 and ≤ 75 years at time of randomization (18 years and older)
• ST-elevation Q wave myocardial infarction
• term admission to an intensive care unit (ICU) in the first 24 hours of onset
• the reperfusion of the infarct-related coronary artery is not later than 24 hours after the initial onset of acute transmural myocardial infarction
• written the informed consent to participate in research

Exclusion criteria

• atrial fibrillation, a permanent form
• valvular heart disease
• severe comorbidity
• acute heart failure according to the Killip classification IV FC (functional class)
• history of chronic heart failure (NYHA III-IV)
• poor image quality for Echocardiography
• sinus bradycardia - heart rate of under 50 beats per minute, interventricular conduction delay (QRS > 0,11 s.) and atrioventricular block II-III degree

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Doxycycline

Experimental group

Description:

100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy

Treatment:

Drug: Doxycycline

Active comparator

Active Comparator group

Description:

Standard care for STEMI

Treatment:

Other: Standard care for STEMI