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NCT04068909Completed

ObseRvation After Acute Coronary Syndrome for deveLopment of trEatment Options

Exacerbation of Coronary Heart Disease: the Logic and Probabilistic Processes of Flow Prediction for Optimization of Treatment

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
1655 (actual)
First submitted
20 Aug 2019
Start date
5 Nov 2014
Primary completion date
20 Feb 2018
Lead sponsor
Central State Medical Academy
NCT number
NCT04068909

What you commit to

  • Study type: Observational
  • Participants enrolled: 1655
  • From 5 Nov 2014 to the primary completion date, 20 Feb 2018
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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)
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.