Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04549805
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2020-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The study aims to take four blood samples from study participants at time of consent if this is done in person and also at time of CTCA in the intervention arm for long-term storage. The sample types and volumes are detailed below:\n\n* Plasma Li-Hep (approx. 4.7ml)\n* Serum Gel (approx. 9ml)\n* EDTA (approx. 4.9ml)\n* EDTA (approx. 9ml) Where possible, surplus serum and/or plasma will also be obtained from the clinical blood samples sent by the clinical care team during the initial hospital attendance.\n\nAll samples will be centrifuged and stored at -80 degrees Celsius.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-10', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Leaman score for overall coronary artery disease burden', 'timeFrame': 'Ideally within 4 weeks of index presentation'}, {'measure': 'Proportion of participants with adverse coronary artery plaque features', 'timeFrame': 'Ideally within 4 weeks of index presentation'}, {'measure': 'Myocardial mass', 'timeFrame': 'Ideally within 4 weeks of index presentation'}, {'measure': 'Proportion of participants with hemodynamically significant coronary stenosis on CT-derived fractional flow reserve (CT-FFR)', 'timeFrame': 'Ideally within 4 weeks of index presentation'}, {'measure': 'Left ventricular volume', 'timeFrame': 'Ideally within 4 weeks of index presentation'}], 'primaryOutcomes': [{'measure': 'Proportion of participants with obstructive coronary artery disease', 'timeFrame': 'Ideally within 4 weeks of index presentation', 'description': 'Proportion of participants with \\>50% stenosis in the left main stem or \\>70% stenosis in other coronary arteries'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with moderate non-obstructive coronary artery disease', 'timeFrame': 'Ideally within 4 weeks of index presentation', 'description': 'Proportion of participants with 50-70% stenosis in one or more coronary arteries'}, {'measure': 'Proportion of participants with mild non-obstructive coronary artery disease', 'timeFrame': 'Ideally within 4 weeks of index presentation', 'description': 'Proportion of participants with 10-50% stenosis in one or more coronary arteries'}, {'measure': 'Proportion of participants with insignificant coronary artery disease', 'timeFrame': 'Ideally within 4 weeks of index presentation', 'description': 'Proportion of participants with 1-10% stenosis in one or more coronary arteries'}, {'measure': 'Proportion of participants with normal coronary arteries', 'timeFrame': 'Ideally within 4 weeks of index presentation', 'description': 'Proportion of participants with no stenosis in coronary arteries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'CT coronary angiography', 'High-sensitivity cardiac troponin'], 'conditions': ['Coronary Artery Disease', 'Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '39097328', 'type': 'DERIVED', 'citation': "Perez-Vicencio D, Thurston AJF, Doudesis D, O'Brien R, Ferry A, Fujisawa T, Williams MC, Gray AJ, Mills NL, Lee KK. Risk scores and coronary artery disease in patients with suspected acute coronary syndrome and intermediate cardiac troponin concentrations. Open Heart. 2024 Aug 3;11(2):e002755. doi: 10.1136/openhrt-2024-002755."}]}, 'descriptionModule': {'briefSummary': 'Most patients presenting to hospital with chest pain are discharged home without further tests once a heart attack has been ruled out. Current strategies to assess patients with a suspected heart attack involve blood tests to measure troponin, a protein released into the bloodstream when the heart muscle is damaged. Despite having had a heart attack ruled-out, some patients have unrecognised coronary heart disease and are at risk of having a heart attack in the future. However, we do not know what is the best approach to identify and treat these patients.\n\nThis study will use a heart scan known as computed tomography coronary angiogram (CTCA) to look for underlying coronary heart disease in patients who have had a heart attack ruled out. In an earlier study, we performed this scan in patients referred to the outpatient cardiology clinic with stable chest pain and found that this improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. Our research has also demonstrated that troponin levels below the threshold used to diagnose a heart attack identify those who are at greater risk of having a heart attack in the future. The aim of this study is to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.', 'detailedDescription': 'Using a newer, more sensitive troponin test, we now know that troponin levels even below the threshold used to diagnose a heart attack identify patients who are at risk of having a heart attack in the future. Our research in patients with stable chest pain demonstrated that computed tomography coronary angiogram (CTCA) improved the diagnosis of coronary heart disease, leading to improvement in patient care that prevented many future heart attacks. This study will build on these two major strands of research to confirm whether these low levels of troponin can identify patients who have underlying coronary heart disease and may benefit from further testing and preventative treatment.\n\nThe investigators will evaluate consecutive patients presenting to hospital with suspected acute coronary syndrome and cardiac troponin concentration within the normal reference range for the presence of underlying coronary artery disease. All participants will be invited for an outpatient CTCA.\n\nFindings from this study will help inform a randomised controlled trial to evaluate the role of CTCA in patients who have a heart attack ruled out, but are identified as intermediate risk on troponin testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (30 years and over) with acute chest pain or equivalent symptoms of suspected acute coronary syndrome and maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presentation to hospital with acute chest pain or equivalent symptoms of suspected acute coronary syndrome\n* Maximum high-sensitivity cardiac troponin I concentration below the 99th centile (16 ng/L for women and 34 ng/L in men)\n\nExclusion Criteria:\n\n* Diagnosis of myocardial infarction during index presentation\n* Clear alternative diagnosis for index presentation\n* Recent CT or invasive coronary angiogram (within 1 year)\n* Patient inability to undergo CT scanning, due to severe renal failure (estimated glomerular filtration rate \\<30 mL/min) or major allergy to iodinated contrast media\n* Pregnancy or breast feeding\n* Inability to give informed consent\n* Further investigation for coronary artery disease would not in the patient's interest, due to limited life expectancy, quality of life or functional status"}, 'identificationModule': {'nctId': 'NCT04549805', 'acronym': 'PRECISE-CTCA', 'briefTitle': 'Troponin to Risk Stratify Patients for Computed Tomography Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Troponin Within the Normal Reference Range to Risk Stratify Patients With Acute Chest Pain for Computed Tomography Coronary Angiography', 'orgStudyIdInfo': {'id': '245971'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without myocardial injury', 'description': 'Patients without myocardial injury will be recruited in a 2:1 fashion stratified by peak high-sensitivity cardiac troponin I concentration above and below a threshold of 5 ng/L.', 'interventionNames': ['Diagnostic Test: Computed Tomography Coronary Angiography']}], 'interventions': [{'name': 'Computed Tomography Coronary Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'In order to optimise the quality of the Computed Tomography Coronary Angiography scan images, participants might be given tablets or an injection (e.g. beta-blockers, calcium channel antagonist, ivabradine) to slow their heart rate and glyceryl trinitrate (GTN) following local protocol guidance.', 'armGroupLabels': ['Patients without myocardial injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Centre for Cardiovascular Science, University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Requests for IPD will be considered on an individual basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'British Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}