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Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction

Evaluation the effect of Trans Sodium Crocetinate(TSC) on re perfusion Injury in Acute Myocardial Infarction with ST elevation segment: a triple-blind, randomized, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120520009801N5
Enrollment
100
Registered
2021-09-13
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI. ST elevation (STEMI) myocardial infarction of unspecified site

Interventions

Intervention 1: Intervention group: Patients under PCI who receive trans sodium crocetinate"""(TSC) at a dose of 0.5 mg / kg body weight by injection within 2 minutes, 5 minutes before PCI, in additio

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 76 Years

Inclusion criteria

Inclusion criteria: Patients should be between 18 and 76 years old Patients with myocardial infarction with an ascending ST segment Meet the entry requirements under the AHA2019 guideline Candidates for PPCI Zero TIMI score at admission

Exclusion criteria

Exclusion criteria: Be pregnant or breastfeeding History of allergy to formulations used in the study.• The patient enters another similar plan and receives other drugs that affect treatment response in the past month The person has cardiogenic shock and is forced to use pressure therapy The patient has IABP History of acute myocardial infarction GFR less than 60 ml / min• Patients with cardiac arrest Patient with VF Patient with hepatic impairment AST / ALT> 5ULN Patient with a history of chronic inflammatory disease Patient with LMCA involvement Patient with a history of myocardial infarction or ACS within 4 hours before the current episode

Design outcomes

Primary

MeasureTime frame
Quantitative amounts of Troponin I Tn I enzyme and drawing the shape of the Tn I time concentration curve. Timepoint: At zero time, 6, 12 and 24 hours after PPCI. Method of measurement: High-Sensitivity Troponin Test-Laboratory.

Secondary

MeasureTime frame
Evaluation of the patient's electrocardiogram and recording of ventricular and supraventricular arrhythmias, number of PVCs, PR / QT / QRS intervals, and evaluation of the cumulative amount of ST segment (STR Percentage). Timepoint: Daily until discharge. Method of measurement: Through ECG examination.;Ejection fraction and evaluation of systolic and diastolic status of all 4 chambers of the heart and LV ENLARGMENT. Timepoint: Daily until discharge. Method of measurement: Echocardiography.;Evaluation of biochemical parameters INR, BUN, Scr Na, K, Ca, Mg, ALT, AST. Timepoint: Daily until discharge. Method of measurement: Laboratory.;Evaluation of the balance between oxidants - antioxidants. Timepoint: Two samples at time zero and patient discharge time. Method of measurement: Laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hooshang Mohammadpour

Mashhad University of Medical Sciences

mohamadpoorah@mums.ac.ir+98 51 1882 3255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026