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

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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

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Cardiovascular Diseases Acute Myocardial Infarction Drug: Doxycycline Other: Standard care for STEMI Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Acute Primary Anterior STEMI (ST Segment Elevation Myocardial Infarction)
Study Start Date : February 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Doxycycline
100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy
Drug: Doxycycline
Doxycycline bid for the first 7 days after primary anterior STEMI
Other Name: Doxycycline Solutab

Active Comparator: Active comparator
Standard care for STEMI
Other: Standard care for STEMI
Invasive and medical treatment for STEMI according to guidelines
Other Name: Invasive and medical treatment for STEMI




Primary Outcome Measures :
  1. Changes in LV end-diastolic volumes index, % [ Time Frame: 14 days and 6 month after STEMI ]

Secondary Outcome Measures :
  1. Incidence of cardiovascular death,% [ Time Frame: 14 days and 6 month after STEMI ]
  2. Incidence of the recurrent myocardial infarction,% [ Time Frame: 14 days and 6 month after STEMI ]
  3. Incidence of the angina,% [ Time Frame: 14 days and 6 month after STEMI ]
  4. Incidence of the heart failure,% [ Time Frame: 14 days and 6 month after STEMI ]
  5. Incidence of the stroke,% [ Time Frame: 14 days and 6 month after STEMI ]
  6. Incidence of the combined endpoint,% [ Time Frame: 14 days and 6 month after STEMI ]
  7. Incidence and severity of adverse events,% [ Time Frame: 14 days and 6 month after STEMI ]
  8. Changes in 2 D global longitudinals strain,Δ % [ Time Frame: 14 days and 6 month after STEMI ]
  9. Changes in MMPs and their inhibitors, other biomarkers, pg/ml [ Time Frame: 14 days and 6 month after STEMI ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02562651


Locations
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Russian Federation
Research Institutite for Cardiology
Tomsk, Tomskii region, Russian Federation, 634012
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
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Principal Investigator: Vyacheslav Ryabov, MD,PhD Research Institute for Cardiology
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Responsible Party: Vyacheslav Ryabov, MD, PhD Research Institute for Cardiology, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02562651    
Other Study ID Numbers: 1202
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Keywords provided by Vyacheslav Ryabov, Russian Academy of Medical Sciences:
STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline
Additional relevant MeSH terms:
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Myocardial Infarction
Vascular Diseases
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents