NON-Invasive Examinations of Coronary Artery Disease (NONCAD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Herning Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT00926458
First received: June 22, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NON-Invasive Examinations of Coronary Artery Disease

Further study details as provided by Herning Hospital:

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.

Substudy CONTRAST

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926458

Locations
Denmark
Cardiovascular Research Unit, Regionhospital Herning Recruiting
Herning, Denmark, 7400
Contact: Ole May, MD, Ph.D.    +4599272088    hecom@ringamt.dk   
Contact: Ole May, MD, Ph.D.    +4526175575    hecom@ringamt.dk   
Principal Investigator: Ole May, MD, Ph.D.         
Sponsors and Collaborators
Herning Hospital
Investigators
Principal Investigator: Ole May, MD, Ph.D. Cardiovascular Research Unit
  More Information

No publications provided

Responsible Party: Ole May, Cardiovascular Research Unit, Region Hospital Herning
ClinicalTrials.gov Identifier: NCT00926458     History of Changes
Other Study ID Numbers: NONCAD
Study First Received: June 22, 2009
Last Updated: June 22, 2009
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 22, 2014