Ischemic Heart DiseaseCT-CA-miRNANCT03855891
Micro-RNA Profile in Patients With Different Stages of Atherosclerosis According to CTA
A study testing blood test in people with Ischemic Heart Disease and Atherosclerosis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Atherosclerosis
- What is being tested?
- blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2019to 1 Oct 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent of the patient to participate in the study;
- Age 18-80;
- The presence of medical indications for MSCT angiography of coronary arteries in connection with suspected coronary heart disease.
Who cannot join
- Age less than 18 or more than 80;
- Pregnancy, breast-feeding;
- Patients who have not undergone (and do not plan) MSCT coronary angiography;
- Any surgical intervention on the heart in history;
- Severe heart failure (III-IV NYHA classes);
- History of myocardial infarction;
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- The body mass index of 35 or more;
- More than twice the ALT and/or AST level;
- The presence of severe somatic pathology (except coronary atherosclerosis);
- Patient's refusal to participate in the study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Circulating Micro-RNA Profile Specificity in Patients With Different Stages of Atherosclerosis According to MSCT Coronary Angiography
The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT).
Read the detailed description
The study will be conducted in two phases. Phase one. After signing the informed consent, patients with coronary heart disease, angina pectoris II-IV functional class, who underwent MSCT angiography of the coronary arteries for medical reasons, regulated in the relevant ESC and the Russian Society of Cardiology guidelines, will be included in the study. According to the results of MSCT, the participants will be divided into 4 groups: those with atherosclerotic plaques with signs of instability; those with stable atherosclerotic plaques without marked calcification; those with calcined atherosclerotic plaques; those with no signs of atherosclerosis of the coronary arteries. Plasma samples will be analyzed by microarray, using a cardiospecific set.
Phase two. Validation of the results obtained after the first phase will be performed on a larger sample of patients. Patients after signing an informed consent will also undergo MSCT angiography of coronary arteries and according to its results will be devided in 4 groups. To assess the level of microRNA expression in the blood of patients, real-time reverse transcription-polymerase chain reaction (RT-PCR) will be used.
The expected result of the study. For the first time ever, there will be determined the profile of circulating regulatory RNA in patients who underwent MSCT angiography of coronary arteries. Features of expression of circulating microRNAs will be compared with different severity degrees of the atherosclerotic process based on MSCT criteria. The results will be compared with each other (including the "control" group), which will allow to identify common patterns and specific differences.
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Being tested
- blood test
- Keywords
- Ischemic Heart Disease, Atherosclerosis, micro-RNA, multislice spiral computed tomography, coronary angiography
- Medical subject headings
- Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
Blood test for spectrum and level of cardiospecific micro-RNA
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | A group of patients with blood tests Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the profile of circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.
Analysis of the spectrum and levels of cardiospecific circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Jan 2019
- Primary completion14 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei N Rozhkov, MD, I.M. Sechenov First Moscow State Medical University
- Investigators
- Philipp Kopylov, Professor, Principal investigator, Sechenov Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855891
- Sponsor's protocol ID
- 1741909-2019
- Acronym
- CT-CA-miRNA
- Status last verified
- Dec 2020
- First submitted
- 25 Feb 2019
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Circulating Micro-RNA Profile Specificity in Patients With Different Stages of Atherosclerosis According to MSCT Coronary Angiography
- ClinicalTrials.gov ID
- NCT03855891
- Acronym / sponsor ID
- CT-CA-miRNA / 1741909-2019
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Keywords
- Ischemic Heart Disease, Atherosclerosis, micro-RNA, multislice spiral computed tomography, coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Feb 2019 (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.
The main purpose of this single-center study is to determine the spectrum and levels of cardiospecific circulating microRNAs in patients with different stages of atherosclerosis according to 640-slice multispiral computed tomography (MSCT).
Detailed description
The study will be conducted in two phases. Phase one. After signing the informed consent, patients with coronary heart disease, angina pectoris II-IV functional class, who underwent MSCT angiography of the coronary arteries for medical reasons, regulated in the relevant ESC and the Russian Society of Cardiology guidelines, will be included in the study. According to the results of MSCT, the participants will be divided into 4 groups: those with atherosclerotic plaques with signs of instability; those with stable atherosclerotic plaques without marked calcification; those with calcined atherosclerotic plaques; those with no signs of atherosclerosis of the coronary arteries. Plasma samples will be analyzed by microarray, using a cardiospecific set.
Phase two. Validation of the results obtained after the first phase will be performed on a larger sample of patients. Patients after signing an informed consent will also undergo MSCT angiography of coronary arteries and according to its results will be devided in 4 groups. To assess the level of microRNA expression in the blood of patients, real-time reverse transcription-polymerase chain reaction (RT-PCR) will be used.
The expected result of the study. For the first time ever, there will be determined the profile of circulating regulatory RNA in patients who underwent MSCT angiography of coronary arteries. Features of expression of circulating microRNAs will be compared with different severity degrees of the atherosclerotic process based on MSCT criteria. The results will be compared with each other (including the "control" group), which will allow to identify common patterns and specific differences.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: blood testA group of patients with blood tests |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent of the patient to participate in the study;
- Age 18-80;
- The presence of medical indications for MSCT angiography of coronary arteries in connection with suspected coronary heart disease.
Key exclusion criteria (10 listed)
- Age less than 18 or more than 80;
- Pregnancy, breast-feeding;
- Patients who have not undergone (and do not plan) MSCT coronary angiography;
- Any surgical intervention on the heart in history;
- Severe heart failure (III-IV NYHA classes);
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 |
|---|---|---|
| blood testBlood test for spectrum and level of cardiospecific micro-RNA | Diagnostic test | Study group |
Primary outcome
Determination of the profile of circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.
Time frame: 2 days
Analysis of the spectrum and levels of cardiospecific circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis.
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 22 Dec 2020.
- Individual participant dataSharing planned: No. Data disclosure is not permitted by the local ethics committee. For more information about the study, you need to contact the principal investigator.
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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.
Philipp Kopylov, Professor principal investigator
Sechenov Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test in people with Ischemic Heart Disease and Atherosclerosis, run by I.M. Sechenov First Moscow State Medical University 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 3 inclusion and 10 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 22 Dec 2020. 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?
Determination of the profile of circulating microRNAs in patients with different degrees of severity of atherosclerotic process on the MSCT criteria basis. (time frame: 2 days). 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 22 Dec 2020.