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

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: NCT02562651
Recruitment Status : Unknown
Verified December 2016 by Vyacheslav Ryabov, Russian Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : September 29, 2015
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Vyacheslav Ryabov, Russian Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 26, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Changes in LV end-diastolic volumes index, % [ Time Frame: 14 days and 6 month after STEMI ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
  • Incidence of cardiovascular death,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence of the recurrent myocardial infarction,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence of the angina,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence of the heart failure,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence of the stroke,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence of the combined endpoint,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Incidence and severity of adverse events,% [ Time Frame: 14 days and 6 month after STEMI ]
  • Changes in 2 D global longitudinals strain,Δ % [ Time Frame: 14 days and 6 month after STEMI ]
  • Changes in MMPs and their inhibitors, other biomarkers, pg/ml [ Time Frame: 14 days and 6 month after STEMI ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI
Official Title  ICMJE Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vascular Diseases
  • Cardiovascular Diseases
  • Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: Doxycycline
    Doxycycline bid for the first 7 days after primary anterior STEMI
    Other Name: Doxycycline Solutab
  • Other: Standard care for STEMI
    Invasive and medical treatment for STEMI according to guidelines
    Other Name: Invasive and medical treatment for STEMI
Study Arms  ICMJE
  • Experimental: Doxycycline
    100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy
    Intervention: Drug: Doxycycline
  • Active Comparator: Active comparator
    Standard care for STEMI
    Intervention: Other: Standard care for STEMI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02562651
Other Study ID Numbers  ICMJE 1202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vyacheslav Ryabov, Russian Academy of Medical Sciences
Study Sponsor  ICMJE Russian Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vyacheslav Ryabov, MD,PhD Research Institute for Cardiology
PRS Account Russian Academy of Medical Sciences
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP