NCT04490928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

July 24, 2020

Last Update Submit

September 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients were admitted to the intensive care unit of the district hospital from November 2018 to February 2019 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. (Included in the registry profile)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sergiyev Posad city hospital

Sergiyev Posad, Moscow Oblast, 141301, Russia

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Vladimir Mazaev

    National Research Center for Therapy and Preventive Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 29, 2020

Study Start

November 1, 2018

Primary Completion

February 28, 2020

Study Completion

July 28, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations