Multicenter Study to Develop a Risk Model for Early Major Cardiovascular Events

NCT02255344 | Completed

• 1 other identifier: R-2014-785-051
• Study Type: observational
• Target: 21,827
• Locations: 1 country
• Sites: 1

Brief Summary

Through the National Registry of patients with ACS in the IMSS (RENASCA IMSS) the investigators will know the real world in terms of risk factors frequency, clinical presentation and its complications, and in the end they can build a risk model for early Major Cardiovascular Events (MACE).

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary Syndromes; Risk Model; National Registry; Comprehensive Care Program; Major Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Major Cardiovascular Events (MACE)

  Follow-up will be done during hospitalization and 30 days, time of most Major Cardiovascular Events presentation (MACE: Reinfarction, myocardial ischemia, heart failure, electrocardiographic complications and / or death ) derived from the timing of initial treatment or lack of it

  up to 1 year

Secondary Outcomes (1)

• medical care cost in Instituto Mexicano del Seguro Social

  30 days and 1 year

Study Arms (2)

ST-Elevation Myocardial Infarction

Consecutive patients of any gender between 18 and 90 years old, diagnosed with ST-Elevation Myocardial Infarction according to international diagnostic criteria - ACC / AHA / ESC, attended in representative hospitals of tertiary and secondary care in the IMSS will be studied

Non ST Segment Elevation

Consecutive patients of any gender between 18 and 90 years old, diagnosed with Non ST Segment Elevation (NSTEMI/ Unstable angina) according to international diagnostic criteria - ACC / AHA / ESC, attended in representative hospitals of tertiary and secondary care in the IMSS will be studied

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients of any gender between 18 and 90 years old, diagnosed with Acute Coronary Syndrome (STEMI/ NSTEMI/ Unstable angina - according to international diagnostic criteria - ACC / AHA / ESC), attended in representative hospitals of tertiary care in the IMSS will be studied.

You may qualify if:

• Consecutive patients of any gender between 18 and 90 years old
• Diagnosed with Acute Coronary Syndrome (STEMI/ NSTEMI/ Unstable angina - according to international diagnostic criteria - ACC / AHA / ESC)

You may not qualify if:

• Cardiomyopathies
• Congenital Disease
• Acute Pulmonary Embolism

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Gabriela Borrayo Sanchez

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Gabriela Borrayo, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Programs Coordinator

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 2, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

ME (1)