NCT03015064

Brief Summary

Prospective cohort evaluating patients in the State of Santa Catarina (Brazil) with the diagnosis of the first acute myocardial infarction from July 2016 until December 2020.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

9.4 years

First QC Date

December 30, 2016

Last Update Submit

July 28, 2024

Conditions

Outcome Measures

Primary Outcomes (16)

  • MACE in 1 year

    Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 1 year

  • MACE in 30 days

    Major cardiovascular events - MACE (cardiovascular death, nonfatal infarction, unstable angina or stroke) in 30 days

  • Death in 1 year

    Death incidence in 1 year

  • Death in 30 days

    Death incidence in 30 days

  • Restenosis in 1 year

    Restenosis incidence in 1 year

  • Restenosis in 30 days

    Restenosis incidence in 30 days

  • Intrastent thrombosis in 1 year

    Intrastent thrombosis incidence in 30 days

  • Intrastent thrombosis in 30 days

    Intrastent thrombosis incidence in 30 days

  • Cardiovascular death in 1 year

    Cardiovascular death incidence in 1 year

  • Cardiovascular death in 30 days

    Cardiovascular death incidence in 30 days

  • Nonfatal infarction in 1 year

    Nonfatal infarction incidence in 1 year

  • Nonfatal infarction in 30 days

    Nonfatal infarction incidence in 30 days

  • Unstable angina in 1 year

    Unstable angina incidence in 1 year

  • Unstable angina in 30 days

    Unstable angina incidence in 30 days

  • Stroke in 1 year

    Stroke incidence in 1 year

  • Stroke in 30 days

    Stroke incidence in 30 days

Secondary Outcomes (33)

  • Epidemiological profile

    Epidemiological profile of hospitalized patients with infarction in Santa Catarina at the admission

  • Fish consumption

    Fish consumption at admission

  • Red meat consumption

    Red meat consumption at admission

  • Chocolate consumption

    Chocolate consumption at admission

  • Caffeine consumption

    Caffeine consumption at admission

  • +28 more secondary outcomes

Study Arms (1)

Myocardial Infarction

Patients with first myocardial Infarction

Other: Myocardial Infarction

Interventions

Observational study of myocardial Infarction patients

Myocardial Infarction

Eligibility Criteria

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

Consecutive patients attended at the Santa Catarina Institute of Cardiology and other hospitals in the State of Santa Catarina with the diagnosis of the first acute myocardial infarction

You may qualify if:

  • Age over 18 years;
  • Presence of precordial pain suggestive of acute myocardial infarction associated with electrocardiogram with new ST segment elevation in two contiguous leads with limits: ≥0.1 mv in all leads other than leads V2-V3 where the following limits apply : ≥0.2 mv in Men ≥40 years; ≥0.25 mV in men \<40 years, or ≥ 0.15 mV in women or presence of precordial pain suggestive of acute myocardial infarction associated with elevation of troponin I or CK-MB above the 99th percentile of the upper reference limit

You may not qualify if:

  • Previous acute myocardial infarction;
  • Disagreement with the Terms of Informed Consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical vice-director

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 9, 2017

Study Start

July 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations