Polyvascular DiseaseKAMMANCT05189847
Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis
An observational study of Polyvascular Disease and Atherosclerosis, run by Eurasian Association of Therapists at 1 site in Russia.
Trial summary
Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyvascular Disease, Atherosclerosis, Atherosclerosis Generalized
- How many people
- 3,059 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2022to 31 Jan 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Anonymized male and female patients over 18 years and suffering MFA confirmed by ultrasound method, ankle-brachial index along with clinical and anamnestic data.
Who may be able to join
- Men or women aged 18 and older at the time of data registration; Presence of 2 or more of the following factors
- Coronary arteries atherosclerosis (atherosclerosis revealed by means of coronary angiography and/or a history of type I myocardial infarction and/or elective PCI and/or CABG and/or angina pectoris with ischemia according to stress test results, history of CHD);
- Lower extremity arteries atherosclerosis (atherosclerotic plaques revealed by ultrasound, and/or ABI <0.9, and/or a history of revascularization, and/or a history of amputation associated due to chronic lower extremities arterial insufficiency);
- Atherosclerosis of brachiocephalic arteries or renal arteries (presence of atherosclerotic plaques according to US data and/or history of revascularization and/or history of atherothrombotic stroke or TIA in the absence of known AF);
- Atherosclerosis of renal arteries or abdominal aorta (presence of atherosclerotic plaques according to US data and/or history of revascularization).
- Presence of one or more of the following atherosclerotic risk factors:
Show all 14Show fewer
- Anamnestic data on dyslipidemia with LDL cholesterol levels above 4.9 mmol/L or total cholesterol levels above 8.0 mmol/L;
- Presence of confirmed familial hypercholesterolemia;
- Current smoker status or history of smoking;
- Overweight (BMI≥ 25 kg/m2);
- Presence of arterial hypertension;
- Presence of established type 2 diabetes mellitus;
- Presence of an established diagnosis of prediabetes;
- Presence of CKD stage 3a and higher (GFR <60 ml / min / 1.73 m2).
Who cannot join
- Life expectancy less than 1 year;
- Patient refusal to participate in the Register
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries
Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries
Read the detailed description
Information on demographics, comorbidities, methods for diagnosing multifocal atherosclerosis (MFA), prescribed therapy, and outcomes will be identified via medical records analysis. Results of arterial bed ultrasound examination (US), results of ankle-brachial index (ABI) measurements, along with clinical and anamnestic data on target organ damage in the MFA-affected areas will be used as the main source verifying the presence MFA.
The follow-up period for each patient will span from the date of inclusion and over the next year with an additional 6 and 12 months of follow-up.
Patients eligible for entry in the Register must be included and their details must be documented. The procedure for obtaining informed consent for the examination and collection of data must comply with the requirements of local legislation. Patients will be required to sign an informed consent document if required.
Standardized electronic CRFs will be used in all research centers. The electronic data collection (EDC) system must be validated in accordance with current standards and legal requirements. Researchers will log into this system using individually assigned usernames and passwords. Data can only be entered and corrected by the researcher or other authorized personnel of the research center.
- Conditions
- Polyvascular Disease, Atherosclerosis, Atherosclerosis Generalized, Cardiovascular Diseases, Cardiac Death, Chronic Kidney Diseases
- Keywords
- Atherosclerosis, polyvascular disease, cardiovascular diseases, acute stroke, acute coronary syndrome, cardiac death, Chronic kidney disease, bleeding, hospitalization, amputation, cardiovascular event, cerebrovascular accident
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Death, Renal Insufficiency, Chronic, Hemorrhage, Stroke, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MFA | Patients with MFA confirmed by ultrasound examination, ABI or using clinical and medical history data. | |
| Patients with a history of established isolated coronary artery disease | The criterion for inclusion of patients in the present study is the diagnosed ischemic heart disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls)
To assess the occurrence of cardiovascular events in 6 and 12 months in a cohort of patients with MFA: brain hemorrhage, acute coronary syndrome, amputation, admission to hospital (related or not related to a cardiovascular disease), number of emergency calls
Measured: after 12 months
Secondary outcomes (5)
All-cause mortality
To estimate overall mortality at 6 and 12 months in a cohort of patients with MFA
Measured: after 12 months
The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity)
To evaluate bleeding at 6 and 12 months in a cohort of patients with MFA
Measured: after 12 months
Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration
To compare the course of CKD in different subpopulations of patients
Measured: after 12 months
Prevalence of risk factors in the population
To estimate the prevalence of risk factors in the population
Measured: after 12 months
Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction)
To evaluate patients according to 3P MACE parameter ((Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction) according to prescribed therapy
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyvascular DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,059 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Eurasian Association of Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Arutyunov, professor, Study chair, Eurasian Association of Therapists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189847
- Sponsor's protocol ID
- KAMMA
- Acronym
- KAMMA
- Status last verified
- Jun 2024
- First submitted
- 28 Dec 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Register Studying the therApeutic Patient Population With Multifocal Atherosclerosis in the Russian Federation and Eurasian Countries
- ClinicalTrials.gov ID
- NCT05189847
- Acronym / sponsor ID
- KAMMA / KAMMA
- Conditions
- Polyvascular Disease, Atherosclerosis, Atherosclerosis Generalized, Cardiovascular Diseases, Cardiac Death, Chronic Kidney Diseases
- Keywords
- Atherosclerosis, polyvascular disease, cardiovascular diseases, acute stroke, acute coronary syndrome, cardiac death, Chronic kidney disease, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,059 participants (actual)
- Lead sponsor
- Eurasian Association of TherapistsUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 13 Jan 2022 (actual)
- 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.
Аn international, multicenter, non-interventional real-life clinical practice Register studying the Actual therapeutic patient population with Multifocal Atherosclerosis in the Russian Federation and Eurasian countries
Detailed description
Information on demographics, comorbidities, methods for diagnosing multifocal atherosclerosis (MFA), prescribed therapy, and outcomes will be identified via medical records analysis. Results of arterial bed ultrasound examination (US), results of ankle-brachial index (ABI) measurements, along with clinical and anamnestic data on target organ damage in the MFA-affected areas will be used as the main source verifying the presence MFA.
The follow-up period for each patient will span from the date of inclusion and over the next year with an additional 6 and 12 months of follow-up.
Patients eligible for entry in the Register must be included and their details must be documented. The procedure for obtaining informed consent for the examination and collection of data must comply with the requirements of local legislation. Patients will be required to sign an informed consent document if required.
Standardized electronic CRFs will be used in all research centers. The electronic data collection (EDC) system must be validated in accordance with current standards and legal requirements. Researchers will log into this system using individually assigned usernames and passwords. Data can only be entered and corrected by the researcher or other authorized personnel of the research center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MFA | – | –Patients with MFA confirmed by ultrasound examination, ABI or using clinical and medical history data. |
| Patients with a history of established isolated coronary artery disease | – | –The criterion for inclusion of patients in the present study is the diagnosed ischemic heart disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anonymized male and female patients over 18 years and suffering MFA confirmed by ultrasound method, ankle-brachial index along with clinical and anamnestic data.
Key inclusion criteria (14 listed)
- Men or women aged 18 and older at the time of data registration; Presence of 2 or more of the following factors
- Anamnestic data on dyslipidemia with LDL cholesterol levels above 4.9 mmol/L or total cholesterol levels above 8.0 mmol/L;
- Presence of confirmed familial hypercholesterolemia;
- Current smoker status or history of smoking;
- Overweight (BMI≥ 25 kg/m2);
Key exclusion criteria (2 listed)
- Life expectancy less than 1 year;
- Patient refusal to participate in the Register
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls)
Time frame: after 12 months
To assess the occurrence of cardiovascular events in 6 and 12 months in a cohort of patients with MFA: brain hemorrhage, acute coronary syndrome, amputation, admission to hospital (related or not related to a cardiovascular disease), number of emergency calls
5 secondary outcomes
All-cause mortality
Time frame: after 12 months
The frequency of any bleeding episodes (life-threatening, bothersome, or of unknown severity)
Time frame: after 12 months
Change of GFR according to Chronic Kidney Disease Epidemiology Collaboration
Time frame: after 12 months
Prevalence of risk factors in the population
Time frame: after 12 months
Change of 3 point major adverse cardiovascular events parameter (Cardiovascular death, Nonfatal stroke, Non-fatal myocardial infarction)
Time frame: after 12 months
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 26 Jun 2024.
- Study designLink provided by the sponsor.
- Peculiarities of polyvascular disease and the diagnostic significance of the ankle-brachial index in patients with coronary artery disease: results from the real-world registry KAMMALink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alexander Arutyunov, professor study chair
Eurasian Association of Therapists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyvascular Disease and Atherosclerosis, run by Eurasian Association of Therapists at 1 site in Russia.
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 14 inclusion and 2 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 26 Jun 2024. 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 Russia. 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.
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?
Occurrence of a cardiovascular event (stroke, ACS, amputation, hospitalizations (related or not to cardiovascular pathology), the number of emergency calls) (time frame: after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2024.