Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT03712020
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2016-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-22', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary artery calcification will be determined by Tc-99m MDP SPECT-CT and Na-F PET-CT', 'timeFrame': '12 months', 'description': 'Na-F has been shown to accumulate in areas of active calcification where contrast CT of the heart has been shown to accumulate in areas of chronic calcification. We aim to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chest Pain']}, 'descriptionModule': {'briefSummary': 'The investigator aims to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.\n\nThe patient cohort will consist of patients diagnosed to have either acute coronary syndrome (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or suspected coronary artery disease (CAD). The PET images will be compared to images obtained from standard contrast CT of the coronaries. This study will provide additional insights about active versus non-active calcification amongst patients with ACS or suspected CAD.', 'detailedDescription': 'Contemporary techniques used to visualize coronary artery calcification include standard non-contrast computed tomography (CT) of the coronaries measuring amount of calcium deposition in the coronaries, contrast CT and more recently, using sodium-fluoride (Na-F) positron emission tomography (PET) to image coronary and valvular calcification. Na-F has been shown to accumulate in areas of active calcification where contrast CT of the heart has been shown to accumulate in areas of chronic calcification. The investigator aims to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.\n\nThe patient cohort will consist of patients diagnosed to have either acute coronary syndrome (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or suspected coronary artery disease (CAD). The PET images will be compared to images obtained from standard contrast CT of the coronaries. This study will provide additional insights about active versus non-active calcification amongst patients with ACS or suspected CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '15 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of acute coronary syndrome\n* Patients referred for workup of suspected coronary syndrome\n* Able to provide written, informed consent.\n* Age between (including) 50 years to 89 years old.\n\nExclusion Criteria:\n\n* Pregnant \\& Lactating women\n* weight \\<=180kg'}, 'identificationModule': {'nctId': 'NCT03712020', 'acronym': 'Active-AMI', 'briefTitle': 'Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct', 'organization': {'class': 'OTHER', 'fullName': 'National Heart Centre Singapore'}, 'officialTitle': 'Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct: A Novel Pilot Study Using Sodium-Fluoride Positron Emission Tomography (PET) and Computed Tomography (CT) Techniques', 'orgStudyIdInfo': {'id': '2014/2183'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Angela Koh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart Centre Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Singapore General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}