NCT01398631

Brief Summary

Various elements of patient history are checked and entered in the admission Case Recor Form (CRF). Three risk scores are calculated out of these elements, combined with physical examination, laboratory values and ECG-findings. The primary aim is to assess the positive and negative predictive values for a cardiovascular event of the three risk scores for chest pain patients. Secondary aim is to assess the sensitivity and specificity of various elements in the patient history for an acute coronary syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

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

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

June 9, 2010

Last Update Submit

February 16, 2016

Conditions

Keywords

Risk scoresACSHEART-score

Outcome Measures

Primary Outcomes (1)

  • Occurence of MACE (Major Adverse Cardiac Events)

    The number of patients diagnosed with MACE (Acute Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting, Significant stenosis with conservative therapy, Death)

    6 weeks after presentation

Secondary Outcomes (2)

  • The number of patients undergoing Coronary ArterioGraphy (CAG)

    Three months after presentation

  • The number of patients suffering Acute Coronary Syndrome (ACS)

    3 months after presentation

Study Arms (1)

Study Group

All included patients presented with chest pain at the emergency room within the inclusion period.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presentating with chest pain in one of the participating hospitals.

You may qualify if:

  • any patient visiting the cardiology emergency room due to chest pain

You may not qualify if:

  • chest pain clearly due to rhythm disturbances or acute heart failure
  • concomitant non cardiac disease with expected fatal outcome within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Meander Medical Centre

Amersfoort, Netherlands

Location

Gelre Hospital

Apeldoorn, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

University Medical Centre Groningen

Groningen, Netherlands

Location

Medical Centrum Haaglanden

Leidschendam, Netherlands

Location

St Antonius Hospital

Nieuwegein, Netherlands

Location

Medical Centre Haaglanden

The Hague, Netherlands

Location

St Antonius Hospital

Utrecht, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

Hofpoort Hospital

Woerden, Netherlands

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Pieter Doevendans, MD,PhD,Prof

    UMC Utrecht

    STUDY CHAIR
  • Barbra Backus, MD

    St Antionius Hospital Nieuwegein

    PRINCIPAL INVESTIGATOR
  • Jacob Six, MD, PhD

    Hofpoort Hospital Woerden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 9, 2010

First Posted

July 20, 2011

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations