Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-21 @ 4:11 AM
Study NCT ID:
NCT04044066
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker-based Prognostic Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'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': 'D002637', 'term': 'Chest Pain'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma, whole blood, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-01', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '12 months', 'description': 'a composite of cardiac death, myocardial infarction or stroke'}, {'measure': 'Major bleeding', 'timeFrame': '12 months', 'description': 'BARC 3 or more bleeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Stable Angina']}, 'referencesModule': {'references': [{'pmid': '37620152', 'type': 'DERIVED', 'citation': 'Wang J, Zhang T, Xu F, Gao W, Chen M, Zhu H, Xu J, Yin X, Pang J, Zhang S, Wei M, Chen J, Liu Y, Yu X, Chew DP, Chen Y. GDF-15 at admission predicts cardiovascular death, heart failure, and bleeding outcomes in patients with CAD. ESC Heart Fail. 2023 Oct;10(5):3123-3132. doi: 10.1002/ehf2.14484. Epub 2023 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.', 'detailedDescription': 'Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'In this prospective, multicenter registry study, we will consecutively enroll eligible patients according to the pre-specified inclusion and exclusion criteria in 6 tertiary hospitals in China. Patients meeting all eligibility criteria will be tracked and their hospitalization data will be collected including baseline clinical and demographic data, risk factors, blood drawn and storage, lab testing results, angiographic and procedural data (if appropriate), medication and adverse events. Clinical follow-up visits will be sheduled at 30 days, 6 months and 12 months after discharge by telephone contact. Follow-up data will be collected and assessment for death (cardiac, non-cardiac), myocardial infarction, stroke, revascularization or bleeding events will be conducted.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)\n2. Age ≥18 years of age and \\<85 years of age\n3. Patient or guardian provided informed written consent\n\nExclusion Criteria:\n\n1. Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)\n2. Patient with non-cardiac co-morbidities with life expectancy less than 12 months\n3. Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge'}, 'identificationModule': {'nctId': 'NCT04044066', 'briefTitle': 'Biomarker-based Prognostic Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)', 'orgStudyIdInfo': {'id': '20172020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Plasma biomarker', 'type': 'BIOLOGICAL', 'description': 'New emerging plasma biomarkers carrying prognositic information'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuguo Chen, MD,PhD', 'role': 'CONTACT', 'email': 'chen919085@126.com', 'phone': '+8618678812777'}], 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuguo Chen, MD,PhD', 'role': 'CONTACT', 'email': 'chen919085@126.com', 'phone': '+8618678812777'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital Hospital', 'class': 'UNKNOWN'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Central Hospital of Zibo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}