Inhibition of cardiac fibrosis by colchicine in acute myocardial infarctio

Not Applicable

Completed

• Conditions: Acute myocardial infarction; Circulatory System

• Registration Number: ISRCTN12958502
• Lead Sponsor: niversity of Brawijaya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-20
• Study Start: 2024-01-02
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients diagnosed with STEMI for the first time, with the following diagnostic criteria: persistent typical chest pain >30 minutes lasting more than 12 hours, accompanied by ST-segment elevation in at least 2 contiguous leads, and an increase in cardiac enzymes, troponin I.
2. Patients who have received information about the study and signed an informed consent.
3. Patients not pregnant, breastfeeding, or planning pregnancy during the study period.
4. Patients without a history of alcohol abuse.
5. Patients not receiving long-term steroid therapy during the study.
6. Patients not currently taking colchicine for other indications (e.g., gout arthritis, familial Mediterranean fever).

Exclusion Criteria

1. Patients with poor medication adherence, as evidenced by the number of missed doses during the study.
2. Patients with a history of hypersensitivity to colchicine.
3. Patients with comorbidities such as infections, inflammation, malignancy, for instance, irritable bowel syndrome (Crohn's Disease or ulcerative colitis), severe renal failure (eGFR <30), a history of hepatic cirrhosis, acute exacerbation of hepatitis, or severe liver disease.
4. Laboratory results as follows: Hemoglobin <11.5g/dl, Leukocytes < 3.0 x 10^9/L, Platelets < 110 x 10^9/L, ALT > 3 times the upper normal limit, Total Bilirubin > 2 times the upper normal limit, Creatinine > 2 times the upper normal limit.
5. Patients who have experienced cardiac arrest.
6. Patients with ventricular fibrillation.
7. Patients with cardiogenic shock or unstable hemodynamics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular remodelling measured using echocardiography during hospitalization and 1 month post-hospitalization

Secondary Outcome Measures

Name	Time	Method
Biomarkers (Gal3, IL10, PIIINP and NTProBNP) measured during hospitalization and 1 month post-hospitalization