Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05825859
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Body Perfusion in Patients With Chest Pain
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfusion in heart, brain and kidneys during rest and adenosine stress, and their associations with psychologic factors and anginal symptoms', 'timeFrame': 'The imaging day', 'description': 'Multiorgan perfusion changes in patients with chest pain'}], 'secondaryOutcomes': [{'measure': 'The association between perfusion in heart, brain and kidneys, and adverse events during five year follow-up', 'timeFrame': 'Five year follow-up after the imaging', 'description': 'Multiorgan perfusion changes in patients with chest pain as related to outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to better understand changes in obstructive coronary artery disease in different organs other than the heart such as the brain and the kidneys using a new generation total body PET scanner.', 'detailedDescription': 'Patients with chest pain and suspected CAD will be studied using total body PET imaging with O15-water perfusion imaging'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Finnish people that have history of chest pain and for which there have been done CTA which shows a possibility for obstructive coronary artery disease. All people in the study population have came to a diagnostic radiowater imgaing to know if there is significant obsturction of the coronary arteries.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented history of chest pain with CT imaging showing a potential for obstructive coronary artery disease\n* Ability to sustain adenosine injection 0.14 mg/kg/min\n\nExclusion Criteria:\n\n* Second or third degree AV-block without pacemaker\n* Sick sinus syndrome\n* Consumption of coffee or aminophylline within 12 hours of administration\n* Recent use of dipyridmole or dipyridamole-containing medications\n* Known hypersensitivity to adenosine\n* Unstable acute MI or acute coronary artery syndrome, and prior cardiac transplantation\n* Active wheezing and bronchospasm\n* Sinus bradycardia with HR\\<40 bmp'}, 'identificationModule': {'nctId': 'NCT05825859', 'acronym': 'KOVERI', 'briefTitle': 'Total Body Perfusion in Patients With Chest Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Total Body Perfusion in Patients With Chest Pain', 'orgStudyIdInfo': {'id': 'KOVERI'}}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Juhani Knuuti, MD', 'role': 'CONTACT', 'email': 'juhani.knuuti@tyks.fi', 'phone': '+358500592998'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Juhani Knuuti, MD', 'role': 'CONTACT', 'email': 'juhani.knuuti@tyks.fi', 'phone': '+358500592998'}], 'overallOfficials': [{'name': 'Juhani Knuuti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Juhani Knuuti', 'investigatorAffiliation': 'Turku University Hospital'}}}}