NCT06048003

Brief Summary

This is a national, multicenter prospective observational study of patients presenting to hospitals in Armenia with STEMI diagnosis. The main questions it aims to answer are:

  • Determine the rate of in-hospital mortality for the patients with STEMI admitted to the participating hospitals.
  • Compare short and long-term CV and all-cause mortality and hospitalization.
  • Determine how professional guidelines are followed in real-world situations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 26, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 15, 2023

Last Update Submit

December 22, 2023

Conditions

Keywords

STEMIMyocardial infarctionacute coronary syndromeCV mortalitybiobanking

Outcome Measures

Primary Outcomes (1)

  • Rate of the in-hospital mortality

    Determine the rate of the in-hospital mortality for the patients with STEMI admitted to the participating hospitals

    During 5 to 7 days of hospitalization

Secondary Outcomes (2)

  • Cardiovascular mortality

    30 days and 12 months

  • All-cause mortality

    30 days and 12 months

Interventions

No specific intervention

Eligibility Criteria

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

The pre-screened population will consist of all patients \>18 years old presenting acutely with suspected STEMI in the participating hospitals. Only patients with confirmed diagnosis of STEMI will be included in the registry, after informed consent signing.

You may qualify if:

  • Adult patient (≥ 18 years of age),
  • Admitted to the participating centers for a STEMI within 48 hours of symptom onset: characterized by a rise and fall of cardiac markers (troponins) together with ST elevation in at least two contagious leads or LBBB.
  • Have given signed informed consent to participate in the study.
  • MI occurring ≤ 48 hours after PCI or CABG
  • The patient or the legal representative refused to sign the informed consent

You may not qualify if:

  • Withdrawal of the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Vanadzor Medical Center

Vanadzor, Lori, Armenia

RECRUITING

Gyumri Medical Center

Gyumri, Shirak, Armenia

RECRUITING

French-Armenian Cardiovascular Center

Goris, Syunik, Armenia

RECRUITING

Heratsi Hospital Complex N1

Yerevan, 0025, Armenia

RECRUITING

Erebouni Medical Center

Yerevan, 0087, Armenia

RECRUITING

Aramyants Medical Center

Yerevan, Armenia

RECRUITING

Armenia Medical Center

Yerevan, Armenia

RECRUITING

Astghik Medical Center

Yerevan, Armenia

RECRUITING

Best Life Medical Center

Yerevan, Armenia

RECRUITING

Nork Marash Medical Center

Yerevan, Armenia

RECRUITING

Shengavit Medical Center

Yerevan, Armenia

RECRUITING

Surb Grigor Lusavorich Medical Center

Yerevan, Armenia

RECRUITING

Yerevan Scientific Medical Center

Yerevan, Armenia

RECRUITING

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Hamlet G Hayrapetyan, Prof.

    Armenian Cardiologists Association

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamlet G Hayrapetyan, Prof.

CONTACT

Hripsime V Poghosyan, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

December 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations