Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-01 @ 10:13 PM
Study NCT ID:
NCT00921856
Status:
RECRUITING
Last Update Posted:
2023-05-31
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003329', 'term': 'Coronary Vasospasm'}, {'id': 'D017566', 'term': 'Microvascular Angina'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-12', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality (cardiac vs. non-cardiac)', 'timeFrame': '12-120 months'}], 'secondaryOutcomes': [{'measure': 'Angina pectoris, repeated angiography, re-admissions for angina pectoris', 'timeFrame': '12-120 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acetylcholine'], 'conditions': ['Coronary Vasospasm', 'Microvascular Angina', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '22322081', 'type': 'DERIVED', 'citation': 'Ong P, Athanasiadis A, Borgulya G, Mahrholdt H, Kaski JC, Sechtem U. High prevalence of a pathological response to acetylcholine testing in patients with stable angina pectoris and unobstructed coronary arteries. The ACOVA Study (Abnormal COronary VAsomotion in patients with stable angina and unobstructed coronary arteries). J Am Coll Cardiol. 2012 Feb 14;59(7):655-62. doi: 10.1016/j.jacc.2011.11.015.'}]}, 'descriptionModule': {'briefSummary': "In patients with chest pain and/or shortness of breath coronary artery disease (CAD) is suspected depending on the pattern of symptoms and the electrocardiogram (ECG). Coronary angiography is the method of choice to verify this suspicion. If the patient coronary arteries on coronary angiography are totally normal or unobstructed, one can only speculate if the patients' discomfort is from the heart or not. A possibility to get further information about the healthiness of the coronary arteries is the acetylcholine test (ACH-test). When injecting this natural, body produced-substance into the coronary arteries one can test if the vessels develop coronary spasm which can be the reason for the patient's symptoms. The investigators therefore use this test in this study to look for coronary spasm in patients with suspected CAD but normal/unobstructed coronary arteries. In case of a positive test, the patient profits from having found a cause for his/her symptoms making treatment with special tablets possible. Furthermore, the investigators want to analyze blood samples of every patient to look for signs of inflammation, vasoconstriction and genetic variants that seem to be linked with coronary spasms. On the basis of these results the ACH-test could probably be avoided in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 35 and 95 years old with angina pectoris and/or dyspnea suggestive of coronary artery disease with non-invasive proof of coronary ischemia or high pre-test probability for CAD who will be referred for coronary angiography\n* Serum creatinine \\< 1,4 md/dl\n* Left ventricular ejection fraction \\> 50%\n\nExclusion Criteria:\n\n* Patients under 35 years and above 95 years of age\n* Severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)'}, 'identificationModule': {'nctId': 'NCT00921856', 'acronym': 'ACOVA', 'briefTitle': 'Abnormal Coronary Vasomotion in Patients With Suspected Coronary Artery Disease (CAD)', 'organization': {'class': 'OTHER', 'fullName': 'Robert Bosch Medical Center'}, 'officialTitle': 'Abnormal Coronary Vasomotion in Patients With Suspected CAD But Normal Coronary Arteries', 'orgStudyIdInfo': {'id': 'ACOVA-1'}, 'secondaryIdInfos': [{'id': 'ACOVA-2', 'type': 'OTHER', 'domain': 'internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CAD', 'description': 'Patients admitted with suspicion of CAD and proof of CAD after coronary angiography.'}, {'type': 'EXPERIMENTAL', 'label': 'No-CAD', 'description': 'Patients admitted with suspicion of CAD but without proof of CAD after coronary angiography will undergo intracoronary acetylcholine provocation test.', 'interventionNames': ['Other: Intracoronary acetylcholine provocation test']}], 'interventions': [{'name': 'Intracoronary acetylcholine provocation test', 'type': 'OTHER', 'description': 'Intracoronary provocation of coronary spasm with acetylcholine in augmented dosages of 2 µg, 20 µg, 100 µg and 200 µg non-selectively in the LCA as well as 80 µg in the RCA. During the procedure, a 12 channel ECG will be recorded.', 'armGroupLabels': ['No-CAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Ong, MD', 'role': 'CONTACT', 'email': 'petereong@gmail.com', 'phone': '+4971181016048'}, {'name': 'Anastasios Athanasiadis, MD', 'role': 'CONTACT', 'phone': '+4971181015444'}], 'facility': 'Robert Bosch Medical Center', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'centralContacts': [{'name': 'Peter Ong, MD', 'role': 'CONTACT', 'email': 'petereong@gmail.com', 'phone': '+4971181015449'}, {'name': 'Andreas Seitz, MD', 'role': 'CONTACT', 'phone': '+4971181015585'}], 'overallOfficials': [{'name': 'Peter Ong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Bosch Medical Center'}, {'name': 'Andreas Seitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert Bosch Medical Center'}, {'name': 'Udo Sechtem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Robert Bosch Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Ong, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Stiftung für Herzforschung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PD Dr. med.', 'investigatorFullName': 'Peter Ong, MD', 'investigatorAffiliation': 'Robert Bosch Medical Center'}}}}