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NCT04068909Befejeződött

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 18.

Rövid összefoglaló (regiszter, angolul)

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

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
1655 (tényleges)
Első benyújtás
2019. aug. 20.
Kezdés
2014. nov. 5.
Elsődleges befejezés
2018. febr. 20.
Fő szponzor
Central State Medical Academy
NCT-szám
NCT04068909

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 1655
  • 2014. nov. 5. és az elsődleges befejezés (2018. febr. 20.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.

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Egyéb

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

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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