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

The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Non-ST-elevation

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.

Study Overview

• Status: Completed
• Conditions: NSTEMI

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 Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow Region
    • Sergiyev Posad, Moscow Region, Russian Federation, 141301
      • Sergiyev Posad city hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): July 28, 2020

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: 10-19/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No