NCT01867801

Brief Summary

The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring 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
11.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

16.9 years

First QC Date

April 24, 2013

Last Update Submit

June 8, 2017

Conditions

Coronary Artery Disease

Keywords

PCICoronary diseaseIschemia

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization.

    24 months

Secondary Outcomes (1)

  • Total mortality

    12 month

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients admitted to Portuguese hospitals for percutaneous coronary intervention

You may qualify if:

  • Patients with:
  • stable angina or,
  • stabilized angina pectoris or,
  • atypical chest pain or,
  • no chest pain but with documented silent ischemia
  • At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
  • Eligible for PCI
  • Informed consent

You may not qualify if:

  • Patients in whom the preferred treatment is CABG;
  • Contra-indication to dual antiplatelet therapy
  • Coronary artery disease precluding PCI
  • A life expectancy of less than 1 year
  • Age under 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNCDC

Coimbra, 3000-306, Portugal

RECRUITING

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseIschemia

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marco Costa, MD

    Portuguese Society of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra M Corker

CONTACT

00351 239 838 101sandra.corker@spc.pt

Study Design

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

Study Record Dates

First Submitted

April 24, 2013

First Posted

June 4, 2013

Study Start

January 1, 2002

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

PT(1)