ST-Elevation Myocardial Infarction Clinical Trial
Official title:
A Comparative Study of Colchicine's Role in Reducing Cardiac Fibrosis in Acute Myocardial Infarction Patients: Evaluating Outcomes With Percutaneous Coronary Intervention Versus Without Reperfusion
Verified date | May 2024 |
Source | University of Brawijaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates the effect of Colchicine in preventing heart structure changes following ST-segment elevation myocardial infarction. Through a clinical trial involving patients requiring coronary intervention, we explore how Colchicine can reduce inflammation and fibrosis, two crucial factors influencing heart failure post-heart attack. The outcomes are expected to offer new insights into post-heart attack treatments to prevent heart failure.
Status | Completed |
Enrollment | 63 |
Est. completion date | November 20, 2023 |
Est. primary completion date | March 25, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Men and women aged 18 years or older. Able and willing to provide informed consent. Presenting with clinical symptoms and supporting examinations indicative of a first-time diagnosis of IMA-EST. Eligible for treatment according to the IMA-STEMI guidelines, which may include: Antiplatelet therapy Renin-angiotensin-aldosterone system inhibitors Beta-blockers Specifically, includes patients who have: Undergone early PCI. Not received reperfusion therapy. Female patients must commit to avoiding pregnancy during the study. Willing to participate in follow-up via face-to-face or telephone contact. Exclusion Criteria: Presence of concurrent diseases such as infections, inflammation, or malignancy. Diagnosed with gastrointestinal disorders including Crohn's disease, ulcerative colitis, or exhibiting chronic diarrhea. Recent abnormal laboratory results (within the last 30 days) including: Hemoglobin below 11.5 g/L Leukocytes below 3.0 x 10^9/L Platelets below 110 x 10^9/L ALT more than three times the upper limit of normal Total bilirubin more than twice the upper limit of normal Creatinine more than twice the upper limit of normal History of liver cirrhosis, acute hepatitis exacerbation, or severe liver disease. Currently pregnant, breastfeeding, or planning to become pregnant during the study. History of alcohol abuse. Receiving long-term steroid therapy or using colchicine for other indications. History of hypersensitivity to colchicine. Severe renal failure (eGFR below 30). History of cardiac arrest, ventricular fibrillation, cardiogenic shock, or hemodynamic instability. Unwilling or unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Tri Astiawati | Tulung Agung | East Java |
Lead Sponsor | Collaborator |
---|---|
University of Brawijaya |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mpact of Colchicine on Ventricular Remodeling in Acute ST-Elevation Myocardial Infarction (STEMI) Patients Post-PCI | This study assesses the impact of colchicine on ventricular remodeling by measuring changes in the expression of NLRP3 inflammasome, TGF-ß, and galectin-3. These biomarkers are indicative of inflammation and fibrotic activity affecting ventricular structure and function in acute STEMI patients post-PCI or without reperfusion therapy | Baseline and 1 month post-intervention |
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