NCT01413282

Brief Summary

The purpose of this study is to determine whether cardiac CT can improve triage of acute chest pain patients in the emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

August 9, 2011

Last Update Submit

August 3, 2016

Conditions

Keywords

Acute coronary syndrome

Outcome Measures

Primary Outcomes (2)

  • Successful discharge rate

    The proportion of patients discharged home without major adverse events during the following 30 days. Major adverse events are cardiovascular death or non-fatal myocardial infarction.

    30 days

  • Diagnostic yield of invasive angiography

    Number of patients identified with severe coronary artery disease identified by invasive angiography requiring revascularisation according to the international guidelines.

    30 days

Secondary Outcomes (8)

  • Successful discharge rate for all adverse events

    30 days

  • Major adverse events

    6 months

  • Acute coronary syndrome

    Index hospital visit

  • Missed myocardial infarctions

    2 days

  • Duration of hospital stay

    Index hospital visit

  • +3 more secondary outcomes

Study Arms (2)

Cardiac CT

ACTIVE COMPARATOR

Triage based on cardiac CT results.

Radiation: Cardiac CT

Standard Care

NO INTERVENTION

Standard diagnostic management according to the European guidelines.

Interventions

Cardiac CTRADIATION

Calcium scan and CT coronary angiography

Cardiac CT

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute chest pain or equivalent
  • Patients older than 30 years
  • Males \< 75 years and Females \< 80 years

You may not qualify if:

  • STEMI
  • Troponin \> 0.1
  • History of known myocardial infarction, PCI or CABG
  • Pregnancy
  • Contrast allergy
  • Renal disfunction
  • No informed consent possible
  • No follow-up possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (1)

  • Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Koen Nieman, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 10, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations