ObseRvation After Acute Coronary Syndrome for deveLopment of trEatment Options

NCT04068909 | Completed

• 1 other identifier: ORACLE-II
• Study Type: observational
• Target: 1,655
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Acute Coronary Syndrome

Keywords

coronary artery disease; death; gene; bleeding; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• all-cause death

  death from any cause

  Number of Participants with end-point during 360 days

Secondary Outcomes (6)

• cardiovascular events

  Number of Participants with end-point during 360 days

• non-fatal myocardial infarction

  Number of Participants with end-point during 360 days

• recurrent acute coronary syndrome

  Number of Participants with end-point during 360 days

• recurrent PCI

  Number of Participants with end-point during 360 days

• complicated atherosclerosis

  Number of Participants with end-point during 360 days

Other Outcomes (1)

• bleeding

  Number of Participants with end-point during 360 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population consists of consistently hospitalized patients with ACS from 4 vascular centers of Moscow, Kazan, Astrakhan and Krasnodar

You may qualify if:

• 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
• 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)

You may not qualify if:

• Lack of patient consent to participate in the study
• Impossibility of contact with the patient after discharge after index event

Sponsors & Collaborators

• Central State Medical Academy: lead

Related Publications (1)

• 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.

  PMID: 33917922 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for DNA analysis in ethylenediaminetetraacetic acid (EDTA)vacutainer tube

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Death; Hemorrhage; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitry A Zateyshchikov, prof

  Central State Medical Academy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 28, 2019
• Study Start: November 5, 2014
• Primary Completion: February 20, 2018
• Study Completion: October 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share