NCT00473863

Brief Summary

The purpose of this study is to determine whether Coronary Computed Tomographic Angiography (CCTA) will increase patient safety by decreasing the rate of missed ACS and adverse events in patients who receive standard care plus CCTA versus standard care alone. Additional goals of the study are to determine whether CCTA can safely reduce the duration of ED visits and the number and duration of hospital admissions.

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
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

May 15, 2007

Last Update Submit

November 19, 2007

Conditions

Acute Coronary SyndromeAcute Myocardial InfarctionUnstable AnginaCoronary DiseaseCoronary Stenosis

Keywords

Acute coronary syndromeAcute myocardial infarctionUnstable anginaCoronary computed tomographic angiographyCoronary AngiographyTomography, X-Ray ComputedTomography, Spiral Computed

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Admission Time

    During initial presentation to hospital

Secondary Outcomes (5)

  • CCU consult time

    During initial presentation to hospital

  • CCU decision time

    During initial presentation to hospital

  • Duration of CCU admission

    During initial presentation to hospital

  • Adverse event rate

    30 days post ED visit

  • All-cause mortality

    30 days post-ED visit

Study Arms (2)

intervention

EXPERIMENTAL

Receives CCTA

Procedure: Coronary Computed Tomographic Angiography

Control

NO INTERVENTION

Interventions

Coronary Computed Tomographic AngiographyPROCEDURE

CCTA will be performed

intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anterior or lateral chest pain
  • years of age or older
  • Fixed address in British Columbia
  • Available for telephone follow-up

You may not qualify if:

  • Low Risk for ACS (all of the following):
  • Age \< 40 years with normal ECG (T wave flattening is the only acceptable abnormality)
  • No prior history of ischemic chest pain (defined as a past diagnosis of MI or angina, previously prescribed nitroglycerine or a clear history of effort related angina)
  • High Risk for ACS (any of the following):
  • Diagnosis consistent with ST elevation myocardial infarction
  • New ST depression ≥ 0.05 mV
  • Troponin \> 0.1
  • Patients with Killip class III or IV heart failure.
  • Hemodynamic instability
  • Previous enrolment in this study.
  • Presence of terminal noncardiac illness.
  • History of angioplasty with stenting and/or grafts.
  • Presence of atrial fibrillation.
  • Contraindication to administration of iodinated contrast agent.
  • Contraindication to beta-blocker administration (eg, asthmatics) AND calcium channel blocker administration.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VGH

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeAngina, UnstableCoronary DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William F Dick, MD

    Vancouver General Hospital

    PRINCIPAL INVESTIGATOR

  • John Mayo, MD

    Vancouver General Hospital

    STUDY DIRECTOR

Central Study Contacts

William F Dick, MD

CONTACT

604 875 4700william.dick@vch.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

November 1, 2007

Study Completion

July 1, 2008

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

CA(1)