Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-03 @ 6:30 AM
Study NCT ID:
NCT03133260
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-19', 'studyFirstSubmitDate': '2017-04-05', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analysis and validation of risk predictors for perioperative major adverse cardiovascular events.', 'timeFrame': 'From the day of surgery until 1 year after surgery', 'description': 'Analyse clinical risk factors for MINS, compare current MACCE clinical risk scores as predictors of MINS and develop a new score for prediction of MINS'}], 'primaryOutcomes': [{'measure': 'Prevalence of myocardial injury after non cardiac surgery (MINS).', 'timeFrame': 'From the day of surgery until the third postoperative day', 'description': 'The aim of the study is to know the prevalence of myocardial injury after non cardiac surgery in high-risk surgical patients. The investigators will perform seriated troponin on the first 3 postoperative days, if troponin value are 30ng/L or more, the investigators will evaluate if troponin increase is due to cardiac or non-cardiac etiology (patients with TEP or sepsis will be excluded). Once the non-cardiac etiology is ruled out, it will be diagnosed of MINS'}], 'secondaryOutcomes': [{'measure': 'Percentage of MINS which corresponds to myocardial infarction', 'timeFrame': 'From the day of surgery until the third postoperative day', 'description': 'Evaluate the percentage of MINS that corresponds to myocardial infarction. In all patients with the diagnosis of MINS the investigators will perform an ECG to evaluate ischemic changes, an echocardiogram to evaluate dyskinesias or akinesia or the presence of ischemic symptoms. If any of them are present, the investigators will diagnose the patient of acute myocardial infarction. So the investigators will compare number of patients who present a MINS with and without myocardial infarction.'}, {'measure': 'Morbimortality in high-risk surgery patients until hospital discharge', 'timeFrame': 'From the day of surgery until hospital discharge or until 30 days after surgery in case the patient still hospitalized', 'description': 'Analyze morbimortality at hospital discharge of all patients included in the study.'}, {'measure': 'Compare the prognosis of patients with MINS versus patients who present a myocardial infarction versus who presented non of them.', 'timeFrame': 'From the day of surgery until 1 year after surgery', 'description': 'To compare short and long term prognosis (hospital discharge, 30 days, 6 months and 1 year after surgery) of patients who presented MINS vs patients who presented myocardial infarction vs patients who did not presented any of them. The investigators will evaluate major cardiovascular events, non-cardiovascular complications and cardiac and all cause mortality.'}, {'measure': 'Morbimortality in high-risk surgery patients 30 days after surgery', 'timeFrame': 'From the day of surgery until 30 days after surgery', 'description': 'Analyze morbimortality at 30 days of all patients included in the study'}, {'measure': 'Morbimortality in high-risk surgery patients 6 months after surgery', 'timeFrame': 'From the day of surgery until 6 months after surgery', 'description': 'Analyze morbimortality at 6 postoperative months of all patients included in the study'}, {'measure': 'Long term morbimortality in high-risk surgery patients', 'timeFrame': 'From the day of surgery until 1 year after surgery', 'description': 'Analyze morbimortality of all patients included in the study 1 year after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardium; Injury']}, 'referencesModule': {'references': [{'pmid': '37043386', 'type': 'DERIVED', 'citation': 'Mases A, Beltran de Heredia S, Gallart L, Roman L, Bosch L, Nunez M, Rueda M, Recasens L, Sabate S. Prediction of Acute Myocardial Injury in Noncardiac Surgery in Patients at Risk for Major Adverse Cardiovascular and Cerebrovascular Events: A Multivariable Risk Model. Anesth Analg. 2023 Dec 1;137(6):1116-1126. doi: 10.1213/ANE.0000000000006469. Epub 2023 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'Major adverse cardiovascular events are the leading cause of perioperative morbimortality in non-cardiac surgery. Perioperative myocardial infarction is usually asymptomatic, with a mortality around 10-12%.\n\nMyocardial Injury in Noncardiac Surgery (MINS), is defined as a myocardial injury that provokes a troponin increase due to myocardial ischemia. MINS is a predictor of morbimortality at short term and at long term.\n\nThe aim of the study is to improve the diagnosis of myocardial injury after non cardiac surgery in high-risk patients, improve its treatment in case of MINS and establish prevention strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both genders over 45 years scheduled for non-urgent surgery with in-hospital stay of 24 hours minimum who require general and or regional anaesthesia (epidural or subarachnoidal) for high-risk surgery or middle risk-surgery with cardiovascular risk factors.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders over 45 years scheduled for non-urgent surgery with in-hospital stay of 24 hours minimum who require general and or regional anaesthesia (epidural or subarachnoidal) that have signed the inform consent who will be operated of:\n\n 1\\. High-risk surgery:\n* Open abdominal aortic aneurism repair\n* Major vascular surgery\n* Major amputations\n* Carotid endarterectomy\n* Duodeno-pancreatic surgery\n* Hepatic resection or resection of biliary duct\n* Esophagectomy\n* Suprarenal resection\n* Cystectomy\n* Pneumonectomy\n\n 2\\. Medium risk-surgery with cardiovascular risk factors (see below):\n* Intraperitoneal surgery (rectum, colon, small bowel, gastric surgery)\n* Peripherical angioplasty\n* Endovascular aneurism repair\n* Head and neck surgery\n* Major orthopedic surgery (hip, knee, column)\n* Major urological or gynecological surgery\n* Thoracic surgery (lobectomy or atypical pulmonary resections)\n\n a) With 1 risk factor:\n* History of coronary artery disease\n* History of cerebrovascular disease (history of transient ischemic attack or stroke)\n* History of congestive heart failure\n* History of vascular disease\n\n b) With 2 risk factors:\n* Diabetes mellitus with medical treatment\n* Renal disease (FGE \\< 45 ml•min-1•1.73m2 )\n* Functional capacity \\< 4METs\n* Intraoperative blood loss \\>600ml\n\nExclusion Criteria:\n\n* Patients without consent information\n* Patients non included in the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03133260', 'briefTitle': 'A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'A Project to Improve the Diagnosis and Prognosis of Myocardial Injury Associated to Non Cardiac Surgery', 'orgStudyIdInfo': {'id': 'MINSMAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non cardiac surgery', 'description': 'Determine perioperative troponin to diagnose perioperative MINS. In case of MINS acetylsalicylic acid and statins will be started if no contraindication. We will follow-up these patients for a year (including cardiologic evaluation after discharge)', 'interventionNames': ['Diagnostic Test: Troponin', 'Drug: Acetylsalicylic acid', 'Drug: Statin']}], 'interventions': [{'name': 'Troponin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Troponin will be measured before surgery and postoperative at days 1,2 and 3.', 'armGroupLabels': ['Non cardiac surgery']}, {'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'description': '100mg acetylsalicylic acid will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery', 'armGroupLabels': ['Non cardiac surgery']}, {'name': 'Statin', 'type': 'DRUG', 'description': '40mg atorvastatin will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery', 'armGroupLabels': ['Non cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Sandra Beltran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthetist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologyst deputy, MD.', 'investigatorFullName': 'Sandra Beltran', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}