Myocardial InfarctionPhase 4PCSAMNCT01700075
Physical and Chemical Study of Atherosclerosis Mechanisms
A Phase 4 study testing Conventional treatment and Weight loss treatment in people with Myocardial Infarction and Coronary Artery Diseases, run by Nazarbayev University at 1 site in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 26 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- Conventional treatment and Weight loss treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteKazakhstan
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Absence of consent form
- Non-compliance of patient to necessary recommendations.
- The presence of mental illness.
- Complete immobilization of a patient (paresis, and paralysis).
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
Scientific Research Institute of Cardiology and Internal Diseases
Almaty, 050000
About this study
Official title: Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention
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.
Read the detailed description
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.
- Conditions
- Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2, Atherosclerosis of Femoral Artery
- Being tested
- Conventional treatment, Weight loss treatment
- Keywords
- atherosclerosis, development of concept, weight loss therapy
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentDrug
Also called Pathogenetic and symptomatic treatment
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.
Weight loss treatmentDietary supplement
Also called vegetable and salt diet
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | 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. Receives: Drug: Conventional treatment |
| Weight loss treatment | Experimental | 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. Receives: Dietary Supplement: Weight loss treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
full recovery from atherosclerotic diseases
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.
Measured: for 12 months
Secondary outcomes (1)
normalised laboratory and instrumental data
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.
Measured: for 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Kazakhstan
- Responsible party
- Sponsor
- Investigators
- Kuat P Oshakbayev, MD, PhD, DsC, Principal investigator, Scientisic research institute of cardiology and internal diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700075
- Sponsor's protocol ID
- 0109RK000079
- Acronym
- PCSAM
- Status last verified
- Oct 2012
- First submitted
- 21 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oshakbayev K, Dukenbayeva B, Otarbayev N, Togizbayeva G, Tabynbayev N, Gazaliyeva M, Idrisov A, Oshakbayev P. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial. Nutr J. 2015 Nov 25;14:120. doi: 10.1186/s12937-015-0108-y.
PubMed 26608649
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Physical and Chemical Study of the Mechanisms of Atherosclerosis With Development of Concept of Treatment and Prevention
- ClinicalTrials.gov ID
- NCT01700075
- Acronym / sponsor ID
- PCSAM / 0109RK000079
- Conditions
- Myocardial Infarction, Coronary Artery Diseases, Diabetes Mellitus, Type 2, Atherosclerosis of Femoral Artery
- Keywords
- atherosclerosis, development of concept, weight loss therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Kazakhstan
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Drug: Conventional treatmentLipidlowering: "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. |
| Weight loss treatment | Experimental | Dietary Supplement: Weight loss treatmentWeight 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. |
Who may qualify
- Ages
- 26 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- Absence of consent form
- Non-compliance of patient to necessary recommendations.
- The presence of mental illness.
- Complete immobilization of a patient (paresis, and paralysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatmentAlso: Pathogenetic and symptomatic treatmentLipidlowering: "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. | Drug | Conventional treatment |
| Weight loss treatmentAlso: vegetable and salt dietWeight 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. | Dietary supplement | Weight loss treatment |
Primary outcome
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.
1 secondary outcome
normalised laboratory and instrumental data
Time frame: for 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 26608649Oshakbayev K, Dukenbayeva B, Otarbayev N, Togizbayeva G, Tabynbayev N, Gazaliyeva M, Idrisov A, Oshakbayev P. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial. Nutr J. 2015 Nov 25;14:120. doi: 10.1186/s12937-015-0108-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuat P Oshakbayev, MD, PhD, DsC principal investigator
Scientisic research institute of cardiology and internal diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional treatment and Weight loss treatment in people with Myocardial Infarction and Coronary Artery Diseases, run by Nazarbayev University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
full recovery from atherosclerotic diseases (time frame: for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01700075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.