- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04068909
ObseRvation After Acute Coronary Syndrome for deveLopment of trEatment Options (ORACLE)
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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
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
Exclusion Criteria:
- Lack of patient consent to participate in the study
- Impossibility of contact with the patient after discharge after index event
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
---|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
all-cause death
Časové okno: Number of Participants with end-point during 360 days
|
death from any cause
|
Number of Participants with end-point during 360 days
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
cardiovascular events
Časové okno: Number of Participants with end-point during 360 days
|
cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
|
Number of Participants with end-point during 360 days
|
non-fatal myocardial infarction
Časové okno: 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
Časové okno: Number of Participants with end-point during 360 days
|
all cases of recurrent myocardial infarction or unstable angina after the index events
|
Number of Participants with end-point during 360 days
|
recurrent PCI
Časové okno: Number of Participants with end-point during 360 days
|
all cases of recurrent PCI after the index hospitalization
|
Number of Participants with end-point during 360 days
|
complicated atherosclerosis
Časové okno: Number of Participants with end-point during 360 days
|
peripheral atherosclerosis need hospitalisation
|
Number of Participants with end-point during 360 days
|
non-fatal stroke
Časové okno: Number of Participants with end-point during 360 days
|
all cases of non-fatal stroke
|
Number of Participants with end-point during 360 days
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
bleeding
Časové okno: Number of Participants with end-point during 360 days
|
all cases of bleeding during and after the index hospitalization
|
Number of Participants with end-point during 360 days
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Dmitry A Zateyshchikov, prof, Central State Medical Academy
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ORACLE-II
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Akutní koronární syndrom
-
Ministry of Public Health, Democratic Republic...National Institutes of Health (NIH); Oregon Health and Science University; National... a další spolupracovníciDokončenoSyndrom neurotoxicity, Cassava | Syndrom neurotoxicity, kyanát | Syndrom neurotoxicity, kyanid | Syndrom neurotoxicity, thiokyanátKongo, Demokratická republika
-
Cliniques universitaires Saint-Luc- Université...UkončenoSyndrom multiorgánové dysfunkce | SEPTICKÝ ŠOK | SYNDROM SEPSEBelgie
-
Massachusetts General HospitalUniversity of California, San DiegoZatím nenabírámeAuto-pivovarský syndrom | Syndrom střevní fermentaceSpojené státy
-
Riphah International UniversityDokončeno
-
Riphah International UniversityDokončenoSyndrom krkuPákistán
-
Mahidol UniversityDokončenoSubakromiální impingement syndrom | Syndrom nárazového ramene | Syndrom subakromiální bolesti | Subakromiální náraz | Impingement syndrom, ramenoIndonésie
-
University Hospital, Strasbourg, FranceZatím nenabírámeSyndrom po pádu | Syndrom psychomotorické disadaptaceFrancie
-
University of ManitobaUkončenoSyndrom patelofemorální bolesti | Syndrom bolesti předního kolena | Patellofemorální syndromKanada
-
Hospices Civils de LyonDokončenoSyndrom toxického šokuFrancie
-
Riphah International UniversityNáborSyndrom horního křížePákistán