NSTEMICONTRASTNCT04490928
The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With NSTEMI
An observational study of NSTEMI, run by National Research Center for Preventive Medicine at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSTEMI
- How many people
- 139 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2018to 28 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Sergiyev Posad city hospital
Sergiyev Posad, Moscow Oblast, 141301
About this study
Official title: 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.
Read the 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
- Conditions
- NSTEMI
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Nov 2018
- Primary completion28 Feb 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSTEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vladimir Mazaev, Study director, National Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490928
- Sponsor's protocol ID
- 10-19/19
- Acronym
- CONTRAST
- Status last verified
- Sep 2020
- First submitted
- 24 Jul 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Non-ST-elevation
- ClinicalTrials.gov ID
- NCT04490928
- Acronym / sponsor ID
- CONTRAST / 10-19/19
- Conditions
- NSTEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause
Time frame: 12 months
Primary Outcome Measures will be evaluated 12 months after the patient is discharged from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Mazaev study director
National Research Center for Therapy and Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSTEMI, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.