Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT00926458
Status:
UNKNOWN
Last Update Posted:
2009-06-23
First Post:
2009-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NON-Invasive Examinations of Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-22', 'studyFirstSubmitDate': '2009-06-22', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stress echocardiography', 'coronary angiography', 'coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The aim of the study is to evaluate the diagnostic value of various non-invasive methods. The study is divided into five substudies:\n\nSubstudy NITRO\n\nPurpose: To investigate whether a subjective effect of Nitroglycerine is associated with significantly narrowed coronary arteries.\n\nThe 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.\n\nSubstudy SCORE\n\nAim: 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.\n\nSubstudy CONTRAST\n\nAim: 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.\n\nSubstudy 2D strain\n\nAim: To Evaluate if lack of increase in 2D strain during adenosine stress echocardiography can predict the presence of narrowed coronary arteries.\n\nSubstudy SPECT\n\nAim: 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.\n\nParticipants: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intermittent episodes of chest pain (more than two attacks, minimum one attack/week)\n2. Signed written informed consent\n3. Sinus rhythm (ECG)\n4. Age above 18 years\n\nExclusion Criteria:\n\n1. Previously (known) myocardial infarction or unstable angina with dynamic changes in the ECG or biomarkers (serology)\n2. CA performed earlier in life\n3. Known significant cardiac valve disease\n4. Asthma (not COPD)\n5. Incapable of performing an exercise test\n6. Malignant Disease\n7. Senile dementia or other conditions causing impaired cooperation\n8. Previous participation in the project\n9. NTG intolerance\n10. Pregnancy\n11. Bundle branch block (QRS \\> 120 ms)\n12. ECG changes:\n\n * Pathologic Q-wave in at least two leads:\n * QS-complex or Q-wave \\> 0.02 sec. in V2-V3\n * QS-complex or Q-wave \\> 0.03 sec. and \\> 0.1 mV in I, II, aVL, aVF or V4-V6\n * Pathologic negative T-wave (in V3-6 and I, II) unless this is part of a left ventricular hypertrophy and strain pattern\n13. Brady pacemaker'}, 'identificationModule': {'nctId': 'NCT00926458', 'acronym': 'NONCAD', 'briefTitle': 'NON-Invasive Examinations of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Herning Hospital'}, 'officialTitle': 'NON-Invasive Examinations of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'NONCAD'}}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ole May, MD, Ph.D.', 'role': 'CONTACT', 'email': 'hecom@ringamt.dk', 'phone': '+4599272088'}, {'name': 'Ole May, MD, Ph.D.', 'role': 'CONTACT', 'email': 'hecom@ringamt.dk', 'phone': '+4526175575'}, {'name': 'Ole May, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiovascular Research Unit, Regionhospital Herning', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Ole May, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herning Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ole May', 'oldOrganization': 'Cardiovascular Research Unit, Region Hospital Herning'}}}}