NCT00926458

Brief Summary

The aim of the study is to evaluate and compare the value of 5 different non-invasive diagnostic methods in patients with chest pain suspected for coronary artery disease. The investigators intend to include 200 patients over a 3 year period in the study. The participants will be recruited from patients referred to coronary angiography at the institution. Before the angiography the participants will (1) test the effect of sublingual Nitroglycerin, (2) give their medical history so mathematical models can estimate the probability of the presence of coronary artery disease, (3) take part in a contrast stress echocardiography and (4) a 2D-strain stress echocardiography and a myocardial scintigraphy. Stenosis found at the angiography will be the gold standard.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

June 22, 2009

Last Update Submit

June 22, 2009

Conditions

Keywords

stress echocardiographycoronary angiographycoronary artery disease

Eligibility Criteria

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

All patients referred for coronary angiography at Region Hospital Herning are screened for the study and all patients complying with the in-/exclusion criteria are invited to participate in the study.

You may qualify if:

  • Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
  • Signed written informed consent
  • Sinus rhythm (ECG)
  • Age above 18 years

You may not qualify if:

  • Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
  • CA performed earlier in life
  • Known significant cardiac valve disease
  • Asthma (not COPD)
  • Incapable of performing an exercise test
  • Malignant Disease
  • Senile dementia or other conditions causing impaired cooperation
  • Previous participation in the project
  • NTG intolerance
  • Pregnancy
  • Bundle branch block (QRS \> 120 ms)
  • ECG changes:
  • Pathologic Q-wave in at least two leads:
  • QS-complex or Q-wave \> 0.02 sec. in V2-V3
  • QS-complex or Q-wave \> 0.03 sec. and \> 0.1 mV in I, II, aVL, aVF or V4-V6
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Unit, Regionhospital Herning

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ole May, MD, Ph.D.

    Cardiovascular Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations