NON-Invasive Examinations of Coronary Artery Disease (NONCAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926458
Recruitment Status : Unknown
Verified June 2009 by Herning Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Information provided by:
Herning Hospital

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.

Condition or disease
Coronary Artery Disease

Detailed Description:

The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:

Substudy NITRO

Purpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.

The participants are instructed to alternate between rest and Nitroglycerine as treatment for chest pain attacks during a 2 week period. Chest pain score is recorded in a diary handed out at day 1 together with 30 tablets Nitroglycerine in the maximal tolerated dose.

Substudy SCORE

Aim: To test and compare the ability of different statistical methods using clinical data to predict the presence of narrowed coronary arteries in a contemporary Danish population.


Aim: To evaluate if the blood flow in an area in the heart muscle measured by contrast adenosine stress echocardiography can predict the presence of significant stenosis in the coronary artery supplying the area.

Substudy 2D strain

Aim: To Evaluate if lack of increase in 2D strain during adenosine stress echocardiography can predict the presence of narrowed coronary arteries.

Substudy SPECT

Aim: To evaluate whether the result of a myocardial scintigraphy can predict symptomatic chest pain relief 6 months after a coronary angiography and possible treatment with balloon or bypass surgery.

Participants: Annually around 1,500 coronary angiographies are performed at Region Hospital Herning. We intend to include 200 patients referred by their physicians to coronary angiography in the study and expect the data collection phase to last 3 years.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NON-Invasive Examinations of Coronary Artery Disease
Study Start Date : January 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)
  2. CA performed earlier in life
  3. Known significant cardiac valve disease
  4. Asthma (not COPD)
  5. Incapable of performing an exercise test
  6. Malignant Disease
  7. Senile dementia or other conditions causing impaired cooperation
  8. Previous participation in the project
  9. NTG intolerance
  10. Pregnancy
  11. Bundle branch block (QRS > 120 ms)
  12. 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
    • Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern
  13. Brady pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926458

Cardiovascular Research Unit, Regionhospital Herning Recruiting
Herning, Denmark, 7400
Contact: Ole May, MD, Ph.D.    +4599272088   
Contact: Ole May, MD, Ph.D.    +4526175575   
Principal Investigator: Ole May, MD, Ph.D.         
Sponsors and Collaborators
Herning Hospital
Principal Investigator: Ole May, MD, Ph.D. Cardiovascular Research Unit

Responsible Party: Ole May, Cardiovascular Research Unit, Region Hospital Herning Identifier: NCT00926458     History of Changes
Other Study ID Numbers: NONCAD
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by Herning Hospital:
stress echocardiography
coronary angiography
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases