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Assessment of the Effects of Atorvastatin Therapy on Myocardial Deformation Characteristics, in Patients With STEMI (CONTRAST)

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ClinicalTrials.gov Identifier: NCT02590653
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Penza State University

Brief Summary:

The primary goal

• To assess the effect of atorvastatin in patients treated since the first 24-96 hours of the disease on the parameters of global and regional myocardial deformation in the infarcted area and the structural and functional properties of arteries at day 7, at 12, 24, 36 and 48 weeks of treatment;

The secondary goals. To evaluate the effect of treatment:

  • on the parameters of the global and regional myocardial deformation in the intact area on day 7, on 12, 24, 36 and 48 weeks of treatment;
  • on the parameters of the global and regional myocardial deformation depending on the degree of coronary blood flow restoration by thrombolysis in myocardial infarction (TIMI)
  • on systolic and diastolic left ventricular function in the presence of initial impairments, or absence of the negative dynamics of these parameters in case of normal baseline values;
  • on the clinical diagnostic criteria for the development or progression of heart failure;
  • the dynamics of the duration and extent of myocardial ischemia according to the daily ECG monitoring on day 7, at 12, 24, 36 and 48 weeks of treatment;
  • the appearance of new prognostically significant cardiac arrhythmias
  • on the pulse wave velocity
  • the thickness of the intima-media complex (IMT); 200 patients are planned to be include in a randomized, single-center, open, prospective, controlled clinical trial, the enrollment will be held at the Department of "Therapy" of Medical Institute of Penza State University.

Definition of the study group:

The patients with STEMI (myocardial infarction with ST-segment elevation) will be included in the study

  • Group 1 STEMI - 100 patients receiving atorvastatin 80 mg / day for 48 weeks;
  • Group 2 STEMI - 100 patients receiving atorvastatin 20 mg / day for 48 weeks Planned number of patients: Pre-Screening - 300 subjects; screening and randomization - 200 subjects.

Patients will be randomized by random number generation to include in the group 1 or 2. All included patients will be on the standard basis therapy of the coronary artery disease, according to the national recommendation.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Atorvastatin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effects of Aggressive Atorvastatin Therapy on Myocardial Deformation Characteristics, Vascular Rigidity, 24 Hour ECG Monitoring Parameters and Quality of Life in Patients With STEMI
Study Start Date : October 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Group A
Group A patients will start atorvastatin at a dose of 80 mg/day between 24 and 96 hours after the onset of STEMI
Drug: Atorvastatin
Lipid-lowering therapy
Other Name: Statin

Active Comparator: Group K
Group K patients will start atorvastatin at a dose of 20 mg/day between 24 and 96 hours after the onset of STEMI
Drug: Atorvastatin
Lipid-lowering therapy
Other Name: Statin




Primary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 2 years ]
    Myocardial infarction, Unstable angina, Cardiac death


Secondary Outcome Measures :
  1. Global myocardial strain in the zone of previous STEMI and in the intact zone after STEMI [ Time Frame: 2 years ]
    two-dimensional strain

  2. Global myocardial strain rate in the zone of previous STEMI and in the intact zone after STEMI [ Time Frame: 2 years ]
    two-dimensional strain

  3. Intima-media thickness of carotid artery [ Time Frame: 2 years ]
    echo-tracking

  4. Carotid-femoral pulse wave velocity [ Time Frame: 2 years ]
    Applanation tonometry

  5. Cardiac-ankle vascular index [ Time Frame: 2 years ]
    Volume sphygmography



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Patients having physical and mental ability to participate in the study
  3. Patients of both sexes aged 35 to 65 years
  4. Presence of documented ST-elevation myocardial infarction confirmed by ECG, as well as troponin I and CK-MB levels.
  5. Presence of hemodynamically relevant stenosis of one artery (i.e., the infarct-related artery) confirmed by coronary angiography (CAG), with the occlusion of other arteries not exceeding 30%.

Exclusion Criteria:

  1. A history of repeat or recurrent myocardial infarction;
  2. A history of chronic heart failure (CHF) III-IV by New-York Heart Association (NYHA);
  3. Presence of left ventricular hypertrophy confirmed by echocardiography;
  4. QRS complex exceeding 1.0;
  5. Ejection fraction less than 40%;
  6. Presence of hemodynamically relevant stenosis exceeding 30% in several coronary arteries confirmed by CAG;
  7. Type 1 diabetes mellitus;
  8. Type 2 diabetes mellitus requiring pharmacotherapeutic correction with insulin;
  9. Any severe concurrent disease;
  10. A history of acute cerebrovascular accident (ACVA) within the 6 month period preceding the study;
  11. Active hepatic disease or liver enzyme elevation of unclear etiology more than 3 times higher than the upper limit of normal;
  12. Hepatic failure or bilirubin elevation more than 1.5 times higher than the upper limit of normal;
  13. Uncontrolled arterial hypertension (AH), with systolic blood pressure (SBP) exceeding 180 mm Hg and diastolic blood pressure (DBP) exceeding 110 mm Hg;
  14. A history of heart rhythm and/or cardiac conduction disorder;
  15. Inborn and/or acquired heart defects;
  16. A history of aortic aneurysm;
  17. Current existence of severe anemia (Hb < 100 g/L);
  18. Chronic renal disease (creatinine clearance < 30 mL/min);
  19. Uncorrected thyroid dysfunction, with hyper- or hypothyroidism;
  20. Intolerance of statins;
  21. Alcohol abuse and drug use;
  22. Participation in other clinical studies within the last two months.

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): NCT02590653


Contacts
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Contact: Valentin Oleynikov, Prof. +78412548229 v.oleynikof@gmail.com

Locations
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Russian Federation
Valentin Oleynikov Recruiting
Penza, Russian Federation, 440026
Contact: Valentin Oleynikov, Prof.    +78412548229    v.oleynikof@gmail.com   
Contact: Nadezhda Sergatskaya, PhD    +78412548229    n.sergatskaya@gmail.com   
Sponsors and Collaborators
Penza State University
Investigators
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Principal Investigator: Valentin Oleynikov, prof. Head of Therapy Department

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Responsible Party: Penza State University
ClinicalTrials.gov Identifier: NCT02590653     History of Changes
Other Study ID Numbers: PSU/T-253
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Penza State University:
STEMI
myocardial strain
atorvastatin
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors