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

NCT ID: NCT02562651

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Vascular Diseases Cardiovascular Diseases Acute Myocardial Infarction

Keywords

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STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline

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

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Doxycycline bid for the first 7 days after primary anterior STEMI

Active comparator

Standard care for STEMI

Group Type ACTIVE_COMPARATOR

Standard care for STEMI

Intervention Type OTHER

Invasive and medical treatment for STEMI according to guidelines

Interventions

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Doxycycline

Doxycycline bid for the first 7 days after primary anterior STEMI

Intervention Type DRUG

Standard care for STEMI

Invasive and medical treatment for STEMI according to guidelines

Intervention Type OTHER

Other Intervention Names

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Doxycycline Solutab Invasive and medical treatment for STEMI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Russian Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Vyacheslav Ryabov

MD, PhD Research Institute for Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vyacheslav Ryabov, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute for Cardiology

Locations

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Research Institutite for Cardiology

Tomsk, Tomskii Region, Russia

Site Status

Countries

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Russia

Other Identifiers

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1202

Identifier Type: -

Identifier Source: org_study_id