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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04490928
Other study ID # 10-19/19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date July 28, 2020

Study information

Verified date September 2020
Source National Medical Research Center for Therapy and Preventive Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study included all patients admitted to the intensive care unit of the district hospital and sent to the angiographic Department for diagnosis and performance of PCI with a diagnosis of NSTEMI, including myocardial infarction (mi) and unstable angina, determined by clinical data, ECG signs and laboratory indicators. Data from patients living in the Sergiev Posad municipal district will be analyzed in order to achieve maximum registration of adverse events during one year of follow-up.


Description:

Objective: to investigate the problem of incomplete myocardial revascularization in percutaneous coronary interventions in patients with acute coronary syndrome without St segment elevation who were admitted to the angiographic Department of the Sergiev Posad city hospital in the Moscow region.

The study will include all patients admitted to the intensive care unit of the regional hospital and sent to the angiographic Department for diagnosis and performance of PCI with acute coronary syndrome NSTEMI, including myocardial infarction (mi) and unstable angina, determined by clinical data, ECG signs and laboratory indicators. Anamnestic, clinical, biochemical indicators, cardiovascular risk factors, comorbid index that determines the course of acute coronary syndrome and prognosis (grace), a number of angiographic data, including the number of affected arteries and variants of the index "syntax score 50" and modified "syntax score 30", "syntax score 70" and" syntax score 90" to separate complete and incomplete revascularization, an integral indicator of the quality of the remaining index Syntex, the absolute value of which is corrected during data analysis. The data of patients living in the city of Sergiev Posad will be reviewed in such a way as to minimize the subsequent year of follow-up, using a telephone survey and the EMIAS electronic system


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date July 28, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients who were referred to an angiographic unit with a diagnosis of NSTEMI for diagnostic coronary angiography and/or PCI from November 2018 to February 2019.

Exclusion Criteria:

- Patients with myocardial infarction with ECG- confirmed ST elevation of more than 1 mm in two leads.

- Residents of areas other than the area in question that may be difficult to contact.

Study Design


Related Conditions & MeSH terms

  • Non-ST Elevated Myocardial Infarction
  • NSTEMI

Locations

Country Name City State
Russian Federation Sergiyev Posad city hospital Sergiyev Posad Moscow Region

Sponsors (1)

Lead Sponsor Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause Primary Outcome Measures will be evaluated 12 months after the patient is discharged from the hospital 12 months
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