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NCT Number: NCT01700075

Physical and Chemical Study of Atherosclerosis Mechanisms

Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical properties of lipid tissues at various localization with subsequent development of concept of treatment and prevention.

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Key information

Conditions

Myocardial Infarction Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerosis of Femoral Artery Cardiovascular Diseases Coronary Artery Disease Coronary Artery Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

26 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scientific Research Institute of Cardiology and Internal Diseases

Almaty, 050000, Kazakhstan

About this study

The chemical and physical properties of different lipids of body. The clinical part of the work is a prospective randomized comparative controlled clinical trial of patients with atherosclerotic diseases.

Developed the concept of "limited biological resources" of the body based on the increase in the expenditure of energy reserves of the body, allowing a critical look at overweight.

The role of overweight in the development of atheromatous fat was revealed. The positive results from the weight loss in patients with atherosclerotic disease were drawn. Developed the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of lipids in hard atherosclerotic fat.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written informed consent form
  • dyslipidemia (HDL <1.0 mmol / l, triglycerides (TG) in plasma ≥ 1,7 mmol / l or cholesterol ≥ 5,6 mmol /l)
  • waist circumference ≥ 94.0 cm in men or ≥ 80,0 cm in women,
  • BP ≥140/95 mm Hg or a patient is taking antihypertensive medications,
  • fasting glucose ≥ 6,1 mmol / l or the patient is taking hypoglycemic agents,
  • the possibility of treatment for 6 months and follow-up for 1 year

Exclusion criteria

  • Absence of consent form
  • Non-compliance of patient to necessary recommendations.
  • The presence of mental illness.
  • Complete immobilization of a patient (paresis, and paralysis).

Treatment and study plan

Conventional Treatment

Drug

Lipidlowering: "Atorvastatin" (Liprimar) - 40mg per day. Antihypertensive: "Diroton" (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and "Ditiazem" (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.

Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day.

Anti-inflammatory: "TromboACC" (acetylsalicylate acid) up to 2 g per day and/or "Clopidogrel" (thienopyridine class antiplatelet agent) - 75mg per day.

Other names: Pathogenetic and symptomatic treatment

Weight loss treatment

Dietary Supplement

Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.

Other names: vegetable and salt diet

Primary outcomes

  1. full recovery from atherosclerotic diseases

    Time frame: for 12 months

    Regression of atherosclerosis plaque in vessel: imaging methods (GE Vivid 7 Ultrasound; GE Healthcare Worldwide USA, Michigan), and computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).

    Improvement of clinical condition: by measurement of clinical presence status.

Secondary outcomes

  1. normalised laboratory and instrumental data

    Time frame: for 12 month

    Weight loss: Tanita-SC330S Body Composition Analyzer (Tanita Corp., Tokyo, Japan) including weight (kg), body mass index (BMI, kg/m2), body composition parameters, including as fat mass (in % of total body weight and total kg), visceral fat rating (units), fat free mass (kg), total body water (in % and kg), muscle mass (in % and kg), bone mass (in % and kg), metabolic age (years), basal metabolic rate (kcal per day), and bioimpedance (Ohms).

    Rate of blood circulation: Dopler Ultrasound (GE Healthcare Worldwide USA, Michigan).

    Bone density: bone densitometry (Lunar Achilles Express Ultrasound; GE Healthcare USA, Madison).

    Imaging of internal organs and blood vessel diameter: computed tomography scans (AG Siemens Somatom Emotion 6, Germany, Muenchen).

    General clinical study of blood and urine, liver and kidneys function tests, glucose and lipids levels.

    Clinical condition in dynamics: clinical presence status.

Sponsors and collaborators

Lead sponsor

Nazarbayev University

Other

Collaborators

  • Ministry of Health, Kazakhstan

Registry information

Official study title

Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention

Acronym: PCSAM

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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