Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI (MASTARD)
Primary Purpose
Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Doxycycline
Standard care for STEMI
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases focused on measuring STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline
Eligibility 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
Sites / Locations
- Research Institutite for Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Doxycycline
Active comparator
Arm Description
100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy
Standard care for STEMI
Outcomes
Primary Outcome Measures
Changes in LV end-diastolic volumes index, %
Secondary Outcome Measures
Incidence of cardiovascular death,%
Incidence of the recurrent myocardial infarction,%
Incidence of the angina,%
Incidence of the heart failure,%
Incidence of the stroke,%
Incidence of the combined endpoint,%
Incidence and severity of adverse events,%
Changes in 2 D global longitudinals strain,Δ %
Changes in MMPs and their inhibitors, other biomarkers, pg/ml
Full Information
NCT ID
NCT02562651
First Posted
July 26, 2015
Last Updated
December 10, 2016
Sponsor
Russian Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02562651
Brief Title
Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
Keywords
STEMI, adverse LVR (left ventricular remodeling), MMPs, Doxycycline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
100 mg of Doxycycline bid for seven days in pts with STEMI underwent PCI (percutaneous coronary intervention) and with current medical therapy
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Standard care for STEMI
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Doxycycline Solutab
Intervention Description
Doxycycline bid for the first 7 days after primary anterior STEMI
Intervention Type
Other
Intervention Name(s)
Standard care for STEMI
Other Intervention Name(s)
Invasive and medical treatment for STEMI
Intervention Description
Invasive and medical treatment for STEMI according to guidelines
Primary Outcome Measure Information:
Title
Changes in LV end-diastolic volumes index, %
Time Frame
14 days and 6 month after STEMI
Secondary Outcome Measure Information:
Title
Incidence of cardiovascular death,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence of the recurrent myocardial infarction,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence of the angina,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence of the heart failure,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence of the stroke,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence of the combined endpoint,%
Time Frame
14 days and 6 month after STEMI
Title
Incidence and severity of adverse events,%
Time Frame
14 days and 6 month after STEMI
Title
Changes in 2 D global longitudinals strain,Δ %
Time Frame
14 days and 6 month after STEMI
Title
Changes in MMPs and their inhibitors, other biomarkers, pg/ml
Time Frame
14 days and 6 month after STEMI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Ryabov, MD,PhD
Organizational Affiliation
Research Institute for Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institutite for Cardiology
City
Tomsk
State/Province
Tomskii region
ZIP/Postal Code
634012
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Changes in Myocardial Biomechanics and Early Short-term Doxycycline Therapy in Patients With Primary Anterior STEMI
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