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Multicenter Study to Develop a Risk Model for Early Major Cardiovascular Events (RENASCA-IMSS)

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ClinicalTrials.gov Identifier: NCT02255344
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriela Borrayo Sanchez, Instituto Mexicano del Seguro Social

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).

Condition or disease
Acute Coronary Syndromes

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicenter Study to Develop a Risk Model for Early Major Cardiovascular Events Based on the IMSS National Registry of Acute Coronary Syndromes (RENASCA IMSS). Stage 1
Study Start Date : August 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Group/Cohort
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



Primary Outcome Measures :
  1. Major Cardiovascular Events (MACE) [ Time Frame: up to 1 year ]
    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


Secondary Outcome Measures :
  1. medical care cost in Instituto Mexicano del Seguro Social [ Time Frame: 30 days and 1 year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Cardiomyopathies
  • Congenital Disease
  • Acute Pulmonary Embolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255344


Contacts
Contact: Gabriela Borrayo, MD +525556276900 ext 21210 gabriela.borrayo@imss.gob.mx
Contact: Eduardo Almeida, MD +525556276900 ext 21230 eduardo.almeida@imss.gob.mx

Locations
Mexico
Gabriela Borrayo Sanchez Recruiting
Mexico City, Mexico, 06720
Contact: Gabriela Borrayo-Sanchez, PhD    5554557050    gabriela.borrayo@imss.gob.mx   
Contact: Eduardo Almeida-Gutierrez, MD    5535007285    eduardo.almeida@imss.gob.mx   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Gabriela Borrayo, MD Instituto Mexicano del Seguro Social

Responsible Party: Gabriela Borrayo Sanchez, Medical Programs Coordinator, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02255344     History of Changes
Other Study ID Numbers: R-2014-785-051
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by Gabriela Borrayo Sanchez, Instituto Mexicano del Seguro Social:
Acute Coronary Syndromes
Risk Model
National Registry
Comprehensive Care Program
Major Cardiovascular Events

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases