Subclinical Hypothyroidism and Acute Coronary Syndrome
Conditions
Interventions
Experimental group:Administer L-T4 treatment
Control group:Administer placebo treatment
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, with written informed consent provided. 2.Hospitalized for acute coronary syndrome (ACS) within 1 month prior to enrollment, and underwent percutaneous coronary intervention (PCI). The presence of at least one non-culprit lesion (stenosis rate 30%–70%) with a lipid arc >90° on the same vessel (confirmed by coronary angiography and IVUS-OCT), located >10 mm away from the target lesion. 3. Subclinical hypothyroidism confirmed by at least two thyroid function tests (with an interval of 7–10 days), defined as free thyroxine (FT4) within the normal reference range and thyroid-stimulating hormone (TSH) elevated but =10 mU/L.
Exclusion criteria
Exclusion criteria: 1. Use of medications affecting thyroid function. 2. Co-existing malignant tumor. 3. Persistent ventricular tachycardia lasting >24 hours post-ischemic reperfusion requiring further intervention. 4. Inability to complete study follow-up or return for scheduled visits. 5. Concurrent participation in another interventional clinical trial. 6. History of allergy to or intolerance of levothyroxine sodium (L-T4). 7. Use of L-T4 within 10 days prior to randomization. 8. Abnormal liver function (liver enzymes >3 times the upper limit of normal). 9. Abnormal renal function (creatinine clearance =50%. 13. Co-existing psychiatric or psychological disorders. 14. Non-adherence to standard secondary prevention for coronary heart disease. 15. Life expectancy <1 year. 16. Pregnancy, breastfeeding, or planned pregnancy in the near future. 17. Any other condition deemed unsuitable for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the minimal fibrous cap thickness (Minimal FCT) when re-examining the target non-criminal plaque using IVUS-OCT 52 weeks later compared to the baseline state; | — |
Secondary
| Measure | Time frame |
|---|---|
| The target non-criminal lesion was found to have a change in the lipid arc angle compared to the baseline as measured by IVUS-OCT (OCT mode);The target non-criminal lesion showed a significant change in macrophage aggregation compared to the baseline as measured by IVUS-OCT (graded 0-4 on the OCT scale);The target non-criminal lesion was measured by IVUS-OCT for its length, load, and the change in the minimum lumen area (in the IVUS mode);The incidence of vascular thin-cap fibrotic plaques in non-criminal lesions as measured by IVUS-OCT compared to the baseline (in the OCT mode);The absolute value changes of blood biochemical indicators compared to the baseline levels (white blood cells, hemoglobin, alanine aminotransferase, aspartate aminotransferase, LDL-C, Lp(a), HDL-C, TG, TC, Cr, Bun), as well as inflammatory indicators (hsCRP, cytokine combination).;Major adverse cardiovascular events (cardiac death, target vessel revascularization, myocardial infarction);All adverse events; | — |
Countries
China
Contacts
Public ContactZheng Yitian; Tang Yida
Peking University Third Hospital
Outcome results
None listed