Adverse Effect of Cardiovascular Medications (Diagnosis)
Conditions
Brief summary
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.
Interventions
DRUGEvolocumab combined with statins
The experimental group was treated with evolocumab combined with statin for lipid-lowering
DRUGStatin
the control group was treated with statin only for lipid-lowering
Sponsors
Zibo Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 50-75 years old, gender unlimited; 2. Diagnosed as coronary atherosclerotic heart disease 3. The informed consent for the study has been signed
Exclusion criteria
1. Those who are unable to cooperate with the examination; 2. Poor imaging quality of refractive interstitial opacity; 3. Macular edema or complicated with macular membrane and senile macular degeneration; 4. Have a history of previous fundus surgery; 5. Those with eye diseases that can cause changes in the microvessels of the fundus; 6. Abnormal elevated intraocular pressure; 7. Moderate or above refractive error (≥ ± 3 diopters) 8. People with cognitive impairment, material dependence, and serious mental illness; 9. Those who do not cooperate with follow-up; 10. Those who participate in other clinical trials at the same time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the main indicator | Up to 12 months | Video disc area (4.5 × 4.5 mm2) of the radial capillary network (RPC) around the nipple and the macular area (6 × 6 mm2), superficial retinal vascular plexus (SCP) and deep retinal vascular plexus (DCP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the secondary indicator | Up to 12 months | The thickness of the retinal nerve fiber layer (RNFL) near the optic disc, the thickness of the retinal ganglion cell layer in the macular region, the area of the avascular zone (FAZ) in the fovea, the changes of blood lipids, and the changes of the diameter of the retinal branch veins near the optic disc |
Countries
China
Contacts
Primary ContactXinyu Wang, Master
Backup ContactLifen Gao, Master
Outcome results
None listed