NCT01642329

Brief Summary

The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients with ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice recommendations for diagnosis and treatment of ACS and monitor its evolution.

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
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2002

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

15.9 years

First QC Date

July 13, 2012

Last Update Submit

October 7, 2016

Conditions

Keywords

Myocardial InfarctionAngina, Unstable

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality in patients admitted for acute coronary syndrome

    Evaluation of hospital mortality rate of patients admitted for acute coronary syndrome

    Hospital dead in patients admitted with acute coronary syndrome

Secondary Outcomes (1)

  • major adverse cardiac events (MACE)

    In-hospital MACE in patients admitted for acute coronary syndrome

Other Outcomes (1)

  • Major bleeding

    In hospital major bleeding

Eligibility Criteria

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

All adult patients with Acute Coronary Syndrome (ACS) with \<48 hours of evolution, admitted to Portuguese Hospitals.

You may qualify if:

  • presence of angina at rest last 48 hours, with: 1) ischemic electrocardiographic changes - ST-segment deviations or negative T waves, and / or 2) elevation of biomarker(cardiac troponin and CK-MB) above the reference value.

You may not qualify if:

  • patients with MI after revascularization procedures (EAM type 4 and 5) and MI type 2 (classification according to the redefinition of Myocardial Infarction, 2007 the Joint ESC / ACCF / AHA / WHF Task Force).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNCDC

Coimbra, Coimbra District, 3000-306, Portugal

RECRUITING

Related Links

Biospecimen

Retention: NONE RETAINED

no samples retained

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Jorge V Mimoso, MD

    Portuguese Society of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra M Corker, Drª

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

January 1, 2002

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations