Acute Coronary SyndromeORACLENCT04068909
ObseRvation After Acute Coronary Syndrome for deveLopment of trEatment Options
An observational study of Acute Coronary Syndrome, run by Central State Medical Academy.
Trial summary
The aim of the study is developing an individualized risk model for the unfavorable outcomes of coronary artery disease and complications from ongoing therapy, according to clinical, instrumental, biochemical and genetic parameters in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,655 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2014to 20 Oct 2025
- 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: Study population consists of consistently hospitalized patients with ACS from 4 vascular centers of Moscow, Kazan, Astrakhan and Krasnodar
Who may be able to join
- Patients with acute coronary syndrome without ST-segment elevation meeting the criteria of a very high, high or intermediate risk, and patients from the low-risk group, if they have episodes of myocardial ischemia in any way Very high risk (1 criterion is sufficient)
- Pulmonary edema, most probably due to ischemia.
- The newly appears or increased noise of mitral regurgitation.
- Rhythm of the gallop, newly developed or intensified wheezing in the lungs.
- Hypotension against ischemia
- Ischemia refractory to treatment
Show all 32Show fewer
- Persistent ventricular tachycardia or the occurrence of ventricular rhythm disturbances during an attack of ischemia High risk
- (1 criterion is sufficient)
- An anginal attack more than 20 minutes within the next 48 hours before admission
- Transitional elevations ST (duration less than 20 min)
- GRACE score > 140 points
- Increased cardiospecific markers of necrosis. (you must have at least 2 criteria)
- Age> 75 years.
- Angina pectoris with transient changes ST> 0.05 mV.
- Intermediate risk (1 criterion is sufficient)
- Age> 75 years.
- Angina pectoris with transient changes ST> 0.05 mV.
- Inversion of the T wave on ECG (≥ 0.2 mV).
- GRACE score 104-139 points
- (it is necessary to have at least 2 criteria)
- Angina of rest (<20 min), stopped spontaneously or with the help of nitroglycerin (NG).
- Anamnesis of pathology of peripheral or cerebral arteries,
- Postponed myocardial infarction, including painless, history of revascularization (PCI or CABG)
- Diabetes.
- Chronic renal failure (GFR <50 mL / min)
- Low risk All other patients with suspicion of ACS require a survey to identify episodes of ischemia
- Patients with acute coronary syndrome with ST-segment elevation
- Patients who were hospitalized with symptoms due to acute myocardial infarction (the duration of infarction is no more than 10 days, by the time of hospitalization) and at least one of the following additional criteria identified upon admission to hospital:
- ST elevation: a persistent ST increase of 1 mm in two adjacent leads from the limbs, or an ST increase of 2 mm in two adjacent thoracic leads
- the appearance of a new left bundle branch block
- dynamics of acute myocardial infarction
- Signed informed consent to participate in the study
Who cannot join
- Lack of patient consent to participate in the study
- Impossibility of contact with the patient after discharge after index event
About this study
Official title: Exacerbation of Coronary Heart Disease: the Logic and Probabilistic Processes of Flow Prediction for Optimization of Treatment
The aim of the study is developing an individualized risk model for the unfavorable outcomes of coronary artery disease and complications from ongoing therapy, according to clinical, instrumental, biochemical and genetic parameters in patients with acute coronary syndrome.
Inclusion criteria: patients with acute coronary syndrome (with or without ST elevation) who have indications for PCI Number of inclusion patients - 1655 patients Scheduled time of follow up - 24 month Primary end-point: all-cause death Secondary end-points: any cardiovascular events (cardiovascular death, nonfatal myocardial infarction, non-fatal stroke); non-fatal myocardial infarction; recurrent acute coronary syndrome; non-fatal stoke; complicated atherosclerosis; recurrent PCI; bleeding
Read the detailed description
The role of genetic factors in the development of coranary heart disease (CHD) exacerbations studied not enough. Most research in this area planned and carried out on a "case-control". Using a similar protocol entails significant errors are associated with a high incidence of subclinical atherosclerotic vascular lesions. Moreover, much of atheroma is extravasal, making it impossible to identify them by angiography. Therefore, necessary to conduct prospective studies to estimate the frequency of so-called hard endpoints. Previously, similar trials were conducted, mainly in connect with drug approving procedures. The spread data from them to other patients directly is not entirely justified. At the same time, the influence of genetic factors in this group of patients can be substantial.
In the previous part of the study, the sample of patients of Moscow, St. Petersburg, Kazan, Chelyabinsk, Stavropol, Perm, and Rostov-on-the-Don was formed, of 1,200 people admitted due to acute coronary syndrome (ACS) including unstable angina and acute myocardial infarction, at coronary care units with follow-up for three years. We found several factors, including genetic, that significantly affect the outcomes of the disease. Coronary atherosclerosis and its complications now considered as a multifactorial disease associated with inherent factors. Therefore, the project provides, besides accounting a significant amount of clinical and instrumental data, the determination of a wide range of genotypes and alleles of polymorphic markers candidate genes encoding the protein factors of the hemostatic system, enzymes of lipid metabolism system, and anti-inflammatory cytokines. It is assumed that the prediction outcomes of coronary heart disease should be carried out taking into account the fact that several factors (gender, diabetes, age, aortic stenosis, atrial fibrillation, etc.) can not only significantly change the forecast itself but also affecting the significance of other risk factors. Since the last study, the standards significantly of ACS management changed. Invasive treatment not only creates opportunities to reduce coronary mortality but also increased demands on the patient's adherence to the assigned medication and creates additional risks associated with its activity (especially with an antithrombotic treatment activity). In these circumstances, the development of personalized approaches to prescribing drugs is particularly important. Thus, the prediction of coronary heart disease outcomes after an ACS on a set of clinical, instrumental, biochemical and genetic indicators is of great importance, as it allows to plan the most optimal treatment for the individual patient.
The aim of the study was to develop a model of individualized risk of coronary heart disease outcomes and side effects of therapy based on clinical and instrumental, biochemical, and genetic parameters in patients with ACS.
- Conditions
- Acute Coronary Syndrome
- Keywords
- coronary artery disease, death, gene, bleeding, atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease, Death, Hemorrhage, Atherosclerosis
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 |
|---|---|---|
| acute coronary syndrome | All patients should receive standard therapy for acute coronary syndrome and concomitant diseases. All drugs are prescribed according current guidelines and approved indications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
death from any cause
Measured: Number of Participants with end-point during 360 days
Secondary outcomes (6)
cardiovascular events
cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
Measured: Number of Participants with end-point during 360 days
non-fatal myocardial infarction
non-fatal myocardial infarction
Measured: Number of Participants with end-point during 360 days
recurrent acute coronary syndrome
all cases of recurrent myocardial infarction or unstable angina after the index events
Measured: Number of Participants with end-point during 360 days
recurrent PCI
all cases of recurrent PCI after the index hospitalization
Measured: Number of Participants with end-point during 360 days
complicated atherosclerosis
peripheral atherosclerosis need hospitalisation
Measured: Number of Participants with end-point during 360 days
non-fatal stroke
all cases of non-fatal stroke
Measured: Number of Participants with end-point during 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start5 Nov 2014
- Primary completion20 Feb 2018
- Study completion20 Oct 2025
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 Acute Coronary SyndromeStudies 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
- 1,655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central State Medical Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larisa Minushkina, Central State Medical Academy
- Investigators
- Dmitry A Zateyshchikov, prof, Principal investigator, Central State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068909
- Sponsor's protocol ID
- ORACLE-II
- Acronym
- ORACLE
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brazhnik VA, Minushkina LO, Boeva OI, Khasanov NR, Kosmacheva ED, Chichkova MA, Zateyshchikov DA. Risk Stratification after an Acute Coronary Syndrome: Significance of Antithrombotic Therapy. J Clin Med. 2021 Apr 8;10(8):1572. doi: 10.3390/jcm10081572.
PubMed 33917922
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation of Coronary Heart Disease: the Logic and Probabilistic Processes of Flow Prediction for Optimization of Treatment
- ClinicalTrials.gov ID
- NCT04068909
- Acronym / sponsor ID
- ORACLE / ORACLE-II
- Conditions
- Acute Coronary Syndrome
- Keywords
- coronary artery disease, death, gene, bleeding, atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,655 participants (actual)
- Lead sponsor
- Central State Medical AcademyUniversity, hospital or other
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 28 Aug 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 aim of the study is developing an individualized risk model for the unfavorable outcomes of coronary artery disease and complications from ongoing therapy, according to clinical, instrumental, biochemical and genetic parameters in patients with acute coronary syndrome.
Inclusion criteria: patients with acute coronary syndrome (with or without ST elevation) who have indications for PCI Number of inclusion patients - 1655 patients Scheduled time of follow up - 24 month Primary end-point: all-cause death Secondary end-points: any cardiovascular events (cardiovascular death, nonfatal myocardial infarction, non-fatal stroke); non-fatal myocardial infarction; recurrent acute coronary syndrome; non-fatal stoke; complicated atherosclerosis; recurrent PCI; bleeding
Detailed description
The role of genetic factors in the development of coranary heart disease (CHD) exacerbations studied not enough. Most research in this area planned and carried out on a "case-control". Using a similar protocol entails significant errors are associated with a high incidence of subclinical atherosclerotic vascular lesions. Moreover, much of atheroma is extravasal, making it impossible to identify them by angiography. Therefore, necessary to conduct prospective studies to estimate the frequency of so-called hard endpoints. Previously, similar trials were conducted, mainly in connect with drug approving procedures. The spread data from them to other patients directly is not entirely justified. At the same time, the influence of genetic factors in this group of patients can be substantial.
In the previous part of the study, the sample of patients of Moscow, St. Petersburg, Kazan, Chelyabinsk, Stavropol, Perm, and Rostov-on-the-Don was formed, of 1,200 people admitted due to acute coronary syndrome (ACS) including unstable angina and acute myocardial infarction, at coronary care units with follow-up for three years. We found several factors, including genetic, that significantly affect the outcomes of the disease. Coronary atherosclerosis and its complications now considered as a multifactorial disease associated with inherent factors. Therefore, the project provides, besides accounting a significant amount of clinical and instrumental data, the determination of a wide range of genotypes and alleles of polymorphic markers candidate genes encoding the protein factors of the hemostatic system, enzymes of lipid metabolism system, and anti-inflammatory cytokines. It is assumed that the prediction outcomes of coronary heart disease should be carried out taking into account the fact that several factors (gender, diabetes, age, aortic stenosis, atrial fibrillation, etc.) can not only significantly change the forecast itself but also affecting the significance of other risk factors. Since the last study, the standards significantly of ACS management changed. Invasive treatment not only creates opportunities to reduce coronary mortality but also increased demands on the patient's adherence to the assigned medication and creates additional risks associated with its activity (especially with an antithrombotic treatment activity). In these circumstances, the development of personalized approaches to prescribing drugs is particularly important. Thus, the prediction of coronary heart disease outcomes after an ACS on a set of clinical, instrumental, biochemical and genetic indicators is of great importance, as it allows to plan the most optimal treatment for the individual patient.
The aim of the study was to develop a model of individualized risk of coronary heart disease outcomes and side effects of therapy based on clinical and instrumental, biochemical, and genetic parameters in patients with ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndrome | – | –All patients should receive standard therapy for acute coronary syndrome and concomitant diseases. All drugs are prescribed according current guidelines and approved indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of consistently hospitalized patients with ACS from 4 vascular centers of Moscow, Kazan, Astrakhan and Krasnodar
Key inclusion criteria (32 listed)
- Patients with acute coronary syndrome without ST-segment elevation meeting the criteria of a very high, high or intermediate risk, and patients from the low-risk group, if they have episodes of myocardial ischemia in any way Very high risk (1 criterion is sufficient)
- (1 criterion is sufficient)
- Intermediate risk (1 criterion is sufficient)
- (it is necessary to have at least 2 criteria)
- Low risk All other patients with suspicion of ACS require a survey to identify episodes of ischemia
Key exclusion criteria (2 listed)
- Lack of patient consent to participate in the study
- Impossibility of contact with the patient after discharge after index event
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
all-cause death
Time frame: Number of Participants with end-point during 360 days
death from any cause
6 secondary outcomes
cardiovascular events
Time frame: Number of Participants with end-point during 360 days
non-fatal myocardial infarction
Time frame: Number of Participants with end-point during 360 days
recurrent acute coronary syndrome
Time frame: Number of Participants with end-point during 360 days
recurrent PCI
Time frame: Number of Participants with end-point during 360 days
complicated atherosclerosis
Time frame: Number of Participants with end-point during 360 days
non-fatal stroke
Time frame: Number of Participants with end-point during 360 days
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 18 Dec 2025.
- Derived from this study: PubMed 33917922Brazhnik VA, Minushkina LO, Boeva OI, Khasanov NR, Kosmacheva ED, Chichkova MA, Zateyshchikov DA. Risk Stratification after an Acute Coronary Syndrome: Significance of Antithrombotic Therapy. J Clin Med. 2021 Apr 8;10(8):1572. doi: 10.3390/jcm10081572.
- 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.
Dmitry A Zateyshchikov, prof principal investigator
Central State Medical Academy
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Central State Medical Academy.
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 32 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
all-cause death (time frame: Number of Participants with end-point during 360 days). 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 NCT04068909, 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 18 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.