CONTRAST: The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With NSTEMI

Sponsor
National Research Center for Preventive Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04490928
Collaborator
(none)
139
1
20.9
6.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    139 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Non-ST-elevation
    Actual Study Start Date :
    Nov 1, 2018
    Actual Primary Completion Date :
    Feb 28, 2020
    Actual Study Completion Date :
    Jul 28, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    complete revascularization

    All patients who underwent complete myocardial revascularization

    incomplete revascularization

    All patients who did not complete myocardial revascularization

    without revascularization

    All patients who were not revascularized

    Outcome Measures

    Primary Outcome Measures

    1. Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause [12 months]

      Primary Outcome Measures will be evaluated 12 months after the patient is discharged from the hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sergiyev Posad city hospital Sergiyev Posad Moscow Region Russian Federation 141301

    Sponsors and Collaborators

    • National Research Center for Preventive Medicine

    Investigators

    • Study Director: Vladimir Mazaev, National Research Center for Therapy and Preventive Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Research Center for Preventive Medicine
    ClinicalTrials.gov Identifier:
    NCT04490928
    Other Study ID Numbers:
    • 10-19/19
    First Posted:
    Jul 29, 2020
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2020