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

Cardiovascular Diseases Clinical Trial

— MASTARD  

Official title:

Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02562651
• Other study ID #: 1202
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: July 26, 2015
• Last updated: December 10, 2016
• Start date: February 2014
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• Vascular Diseases

Intervention

Drug:
• Doxycycline
Doxycycline bid for the first 7 days after primary anterior STEMI

Other:
• Standard care for STEMI
Invasive and medical treatment for STEMI according to guidelines

Locations

Country	Name	City	State
Russian Federation	Research Institutite for Cardiology	Tomsk	Tomskii region

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in LV end-diastolic volumes index, %		14 days and 6 month after STEMI
Secondary	Incidence of cardiovascular death,%		14 days and 6 month after STEMI
Secondary	Incidence of the recurrent myocardial infarction,%		14 days and 6 month after STEMI
Secondary	Incidence of the angina,%		14 days and 6 month after STEMI
Secondary	Incidence of the heart failure,%		14 days and 6 month after STEMI
Secondary	Incidence of the stroke,%		14 days and 6 month after STEMI
Secondary	Incidence of the combined endpoint,%		14 days and 6 month after STEMI
Secondary	Incidence and severity of adverse events,%		14 days and 6 month after STEMI
Secondary	Changes in 2 D global longitudinals strain,? %		14 days and 6 month after STEMI
Secondary	Changes in MMPs and their inhibitors, other biomarkers, pg/ml		14 days and 6 month after STEMI