Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:51 AM
Study NCT ID:
NCT07435168
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}, {'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ATTR-CA in patients experiencing chest pain', 'timeFrame': 'Up to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Amyloidosis', 'Chest Pain']}, 'descriptionModule': {'briefSummary': 'The objective of this observational, prospective study is to determine the prevalence of Cardiac Amyloidosis (CA) in males over the age of 65 who experience chest pain but show no signs of coronary artery disease (CAD).\n\nPrior to inclusion, all patients will have undergone a CT coronary angiogram or an Rb-PET scan to rule out the possibility of CAD.\n\nParticipants will be subject to several examinations, including blood tests, urine samples, ECG, echocardiography, and bone scintigraphy. An endomyocardial biopsy may be conducted if necessary.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNo signs of CAD through Rb-PET and/or CT coronary arteriogram\n\nExclusion Criteria:\n\nPrevious history of amyloidosis'}, 'identificationModule': {'nctId': 'NCT07435168', 'acronym': 'CHEST-CA', 'briefTitle': 'CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'CHEST-CA: Study of Chest Pain and Hidden Cardiac Amyloidosis', 'orgStudyIdInfo': {'id': 'H-24002324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Interventional group', 'interventionNames': ['Other: Screening thourgh examinations including bonescintigraphy']}], 'interventions': [{'name': 'Screening thourgh examinations including bonescintigraphy', 'type': 'OTHER', 'description': 'Clinical examination, blood samples, echo, bone scintigraphy', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Navid Noory, MD', 'role': 'CONTACT', 'email': 'navid.noory@regionh.dk', 'phone': '+4535453108'}, {'name': 'Emil Fosbøl, MD,', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Navid Noory, MD, Phd-fellow', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Navid Noory, MD', 'role': 'CONTACT', 'email': 'navid.noory@regionh.dk', 'phone': '4535453108'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor, Consultant Cardiologist, DMSc', 'investigatorFullName': 'Emil Loldrup Fosbol', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}