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IRCT20231125060174N1 IRCT 2023-12-08 Zahedan University of Medical Sciences Effect of Curcumin in the prevention of Peri-procedural Myocardial Injury Effect of Curcumin in the prevention of Peri-procedural Myocardial Injury following Percutaneous Coronary Intervention (PPMI) 2024-02-20 anticipated 108 Complete https://irct.ir/trial/74036 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Blinding description: People have been blinded: Participant and Data analyzer Curcumin and placebo are completely similar in shape, color and administration method. 1-2 Peri-procedural Myocardial Injury. Intervention 1: Intervention group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with 1000 mg per day Oral administration of Curcumin that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography (1000mg- 3 days before PCI). Intervention 2: Control group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with Oral administration of Placebo that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Kaveh OraiiYazdani
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3341 2040 dr.k.o.yazdani@zaums.ac.ir Zahedan University of Medical Sciences scientific Kaveh OraiiYazdani
Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743111 +98 54 3341 2040 dr.k.o.yazdani@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients with ischemic heart disease and candidates for PCI or acute coronary syndrome who referred for coronary angiography with a possible clinical indication for PCI Patients with acute coronary syndrome and candidates for PCI Patients have undergone elective and non-emergency PCI Consent to participate in the present study 18 years 80 years Both using the oral steroid drugs or NSAIDs except aspirin Active malignancy or infection History of Myelodysplasia Severe Hepatic dysfunction (AST or ALT more than 3 times UMN) Pregnancy Renal dysfunction (serum creatinine more than 2.5 mg/dL or undergoing dialysis) History of revascularization (PCI or CABG) S26.9 Injury of heart, unspecified with or without hemopericardium Prevention Prevention Intervention group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with 1000 mg per day Oral administration of Curcumin that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography (1000mg- 3 days before PCI) Control group: Receive the standard pretreatment protocol in patients undergoing Percutaneous Coronary Intervention (aspirin, and Clopidogrel) along with Oral administration of Placebo that prepared in Mashhad Faculty of Pharmacy, for 3 days before angiography Serum levels of hs-Troponin-I. Timepoint: before PCI and 24 hours after PCI. Method of measurement: Immunoassay. Serum levels of hs-CRP. Timepoint: before PCI and 24 hours after PCI. Method of measurement: Immunoassay. Stent thrombosis. Timepoint: 30 days after PCI. Method of measurement: Observation, ECG, Echocardiography. Zahedan University of Medical Sciences Approved 2023-11-20 Ethics committee of Zahedan University of Medical Sciences Imam Ali Research Hospital, Persian Gulf Highway, Zahedan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)