NON-Invasive Examinations of Coronary Artery Disease (NONCAD)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2009 | ||||
| Last Updated Date | June 22, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NON-Invasive Examinations of Coronary Artery Disease | ||||
| Official Title ICMJE | NON-Invasive Examinations of Coronary Artery Disease | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00926458 | ||||
| Other Study ID Numbers ICMJE | NONCAD | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ole May, Cardiovascular Research Unit, Region Hospital Herning | ||||
| Study Sponsor ICMJE | Herning Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Herning Hospital | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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