NON-Invasive Examinations of Coronary Artery Disease (NONCAD)
Recruitment status was Recruiting
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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 |
| 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) |
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 |
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:
- Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)
- Signed written informed consent
- Sinus rhythm (ECG)
- Age above 18 years
Exclusion Criteria:
- 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
- Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern
- Brady pacemaker
Contacts and 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. | |
| 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 Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013