Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-04-09 @ 12:29 PM
Study NCT ID:
NCT06123793
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no-reflow PIANO score as predictor of cumulative MACE', 'timeFrame': '3 months', 'description': 'Assess the role of The PIANO ( PredIction of Angiographic NO-reflow ) score as a predictor of cumulative (in-hospital and short-term) MACE over 3 months period in STEMI patients undergoing primary PCI\n\nThe PIANO score ranges from 0 - 14 and it predicts NO Reflow (a complication of PCI), patients with higher scores have a higher risk of developing NO Reflow as a complication\n\nThe PIANO score depends on the following:\n\n* Age ≥70 years,( 2 points )\n* absence of pre-infarction angina ( 3 points )\n* total ischemic time ≥4 h ( 1 point )\n* left anterior descending as the culprit artery ( 1 point )\n* pre-PCI TIMI flow grade ≤1 ( 2 points ) pre-PCI TIMI thrombus score ≥4 ( 5 points )\n\nwe will look if patients undergoing primary PCI with high PIANO scores will have a higher risk of poor outcomes.'}, {'measure': 'culprit-SYNTAX score as predictor of cumulative MACE', 'timeFrame': '3 months', 'description': 'SYNTAX score ( Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) is a well-known score that assesses the severity and complexity of coronary artery disease and helps in choosing a treatment plan.\n\n\\- it ranges from 0 with no predefined maximum score, and it is calculated according to several angiographic parameters using this online calculator tool:https://syntaxscore.org/calculator/start.htm).\n\nthe SYNTAX score can be calculated only for the culprit vessel ( culprit-SYNTAX) score\n\nwe will look if patients undergoing primary PCI with high culprit-SYNTAX scores will have a higher risk of poor outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['STEMI']}, 'referencesModule': {'references': [{'pmid': '30322265', 'type': 'BACKGROUND', 'citation': 'Tanik VO, Cinar T, Arugaslan E, Karabag Y, Hayiroglu MI, Cagdas M, Rencuzogullari I, Uluganyan M. The Predictive Value of PRECISE-DAPT Score for In-Hospital Mortality in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Angiology. 2019 May;70(5):440-447. doi: 10.1177/0003319718807057. Epub 2018 Oct 15.'}, {'pmid': '10547403', 'type': 'BACKGROUND', 'citation': "Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901."}, {'pmid': '25042419', 'type': 'BACKGROUND', 'citation': 'Taniwaki M, Stefanini GG, Raber L, Brugaletta S, Cequier A, Heg D, Iniguez A, Kelbaek H, Serra A, Ostoijic M, Hernandez-Antolin R, Baumbach A, Blochlinger S, Juni P, Mainar V, Sabate M, Windecker S. Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials. EuroIntervention. 2015 Aug;11(4):391-8. doi: 10.4244/EIJY14M07_12.'}, {'pmid': '32395313', 'type': 'BACKGROUND', 'citation': 'Hizoh I, Domokos D, Banhegyi G, Becker D, Merkely B, Ruzsa Z. Mortality prediction algorithms for patients undergoing primary percutaneous coronary intervention. J Thorac Dis. 2020 Apr;12(4):1706-1720. doi: 10.21037/jtd.2019.12.83.'}, {'pmid': '24671913', 'type': 'BACKGROUND', 'citation': 'Ayca B, Akin F, Celik O, Cetin S, Sahin I, Gulsen K, Kalyoncuoglu M, Katkat F, Okuyan E, Dinckal MH. Does SYNTAX score predict in-hospital outcomes in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention? Kardiol Pol. 2014;72(9):806-13. doi: 10.5603/KP.a2014.0064. Epub 2014 Mar 27.'}, {'pmid': '37504526', 'type': 'BACKGROUND', 'citation': 'Peker T, Boyraz B. Short-Term Prognostic Value of the Culprit-SYNTAX Score in Patients with Acute Myocardial Infarction. J Cardiovasc Dev Dis. 2023 Jun 24;10(7):270. doi: 10.3390/jcdd10070270.'}, {'pmid': '20488311', 'type': 'BACKGROUND', 'citation': 'Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.'}, {'pmid': '32932736', 'type': 'BACKGROUND', 'citation': 'Pantea-Rosan LR, Pantea VA, Bungau S, Tit DM, Behl T, Vesa CM, Bustea C, Moleriu RD, Rus M, Popescu MI, Turi V, Diaconu CC. No-Reflow after PPCI-A Predictor of Short-Term Outcomes in STEMI Patients. J Clin Med. 2020 Sep 12;9(9):2956. doi: 10.3390/jcm9092956.'}, {'pmid': '34596236', 'type': 'BACKGROUND', 'citation': 'Dai C, Liu M, Zhou Y, Lu D, Li C, Chang S, Chen Z, Qian J, Ge J. A score system to predict no-reflow in primary percutaneous coronary intervention: The PIANO Score. Eur J Clin Invest. 2022 Feb;52(2):e13686. doi: 10.1111/eci.13686. Epub 2021 Oct 11.'}, {'pmid': '37574024', 'type': 'BACKGROUND', 'citation': 'Dai C, Yang Z, Liu M, Zhou Y, Lu D, Chang S, Li C, Lu H, Chen Z, Qian J, Ge J. Prognostic value and clinical usefulness of PIANO score in patients undergoing primary percutaneous coronary intervention. Int J Cardiol. 2023 Nov 1;390:131258. doi: 10.1016/j.ijcard.2023.131258. Epub 2023 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to assess the culprit-SYNTAX score and no-reflow PIANO scores as possible predictors of in-hospital and short-term outcomes among patients with STEMI undergoing primary PCI', 'detailedDescription': 'ST-elevation myocardial infarction (STEMI) is the leading cause of death in cardiovascular patients. Percutaneous coronary intervention (PCI) is recommended as the preferred treatment for patients with STEMI. However, patients with (STEMI) undergoing primary (PCI) remain at high risk of adverse events, including death, reinfarction, stent thrombosis, and repeat revascularization. This underlines the need to identify predictors of impaired clinical outcomes in order to recognize higher-risk patients in the contemporary practice of primary PCI. STEMI patients show variable mortality risks, in order to assess individual risk, a number of mathematical models (scoring algorithms) have been developed as TIMI, GRACE 2.0, and ALPHA scores Similarly, angiographic scores were developed to assess the outcomes in STEMI patients, SYNTAX Score, has shown predictive value of in-hospital mortality among STEMI patients. Recently, the culprit-SYNTAX score appears to be as successful as the SYNTAX score in predicting stent thrombosis in patients with ACS and more successful in predicting 30-day deaths and major complications.\n\nThe no-flow phenomenon (NRP), one of the most common complications of primary PCI, significantly reduces the benefit of this procedure. The occurrence of NRP following PPCI leads to an unfavorable short-term prognosis by increasing the risk of complications and in some cases, of death. A new score system (the PIANO score) based on six clinical variables was constructed and validated, was variables to predict angiographic no-reflow in STEMI patients undergoing primary PCI, and very recently showed potential prognostic value in patients with AMI undergoing primary PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients presenting to Assiut University Heart Hospital with STEMI and undergoing primary PCI, each patient will be followed up 3 months post-PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients presented with 1st episode of STEMI and undergoing primary PCI. For 1 year duration.\n\n\\-\n\nExclusion Criteria:\n\n1. Patient with STEMI in which thrombolytic therapy was used.\n2. Patient with a history of previous CABG surgery.\n3. Patient with a history of previous PCI.\n4. Patient with a history of previous STEMI.\n5. Patients with myocardial infarction with non-obstructive coronary arteries (MINOCA)\n6. Patient with spontaneous coronary artery dissection (SCAD).'}, 'identificationModule': {'nctId': 'NCT06123793', 'briefTitle': 'Predictors of In-hospital and Short-term Clinical Outcomes in STEMI Patients Undergoing Primary PCI', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Culprit-SYNTAX Score and No-reflow PIANO Score as Predictors of In-hospital and Short-term Clinical Outcomes in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'Predictors of outcomes in MI'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahman Ragab', 'role': 'CONTACT'}], 'facility': 'Abdelrahman Ragab', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Abdelrahman R. Kamel, MBBS', 'role': 'CONTACT', 'email': 'Ab.ragabk@gmail.com', 'phone': '+20 01002251849'}, {'name': 'Heba M. El-Naggar, PhD', 'role': 'CONTACT', 'email': 'heba_m_elnaggar@yahoo.com', 'phone': '+20 01001963100'}], 'overallOfficials': [{'name': 'Salwa R. Demitry, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor at cardiovascular medicine department , assiut university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Abdelrahman Ragab Kamel', 'investigatorAffiliation': 'Assiut University'}}}}