Back to resultsEffect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Primary Purpose
Adverse Effect of Cardiovascular Medications (Diagnosis)
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Evolocumab combined with statins
Statin
Sponsored by
About this trial
This is an interventional treatment trial for Adverse Effect of Cardiovascular Medications (Diagnosis)
Eligibility Criteria
Inclusion Criteria: Age 50-75 years old, gender unlimited; Diagnosed as coronary atherosclerotic heart disease The informed consent for the study has been signed Exclusion Criteria: Those who are unable to cooperate with the examination; Poor imaging quality of refractive interstitial opacity; Macular edema or complicated with macular membrane and senile macular degeneration; Have a history of previous fundus surgery; Those with eye diseases that can cause changes in the microvessels of the fundus; Abnormal elevated intraocular pressure; Moderate or above refractive error (≥ ± 3 diopters) People with cognitive impairment, material dependence, and serious mental illness; Those who do not cooperate with follow-up; Those who participate in other clinical trials at the same time
Sites / Locations
- Zibo Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental Group
Control Group
Arm Description
evolocumab combined with statins
statins only
Outcomes
Primary Outcome Measures
the main indicator
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 Outcome Measures
the secondary indicator
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05802108
Brief Title
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Official Title
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zibo Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effect of Cardiovascular Medications (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
evolocumab combined with statins
Arm Title
Control Group
Arm Type
Other
Arm Description
statins only
Intervention Type
Drug
Intervention Name(s)
Evolocumab combined with statins
Other Intervention Name(s)
drug1
Intervention Description
The experimental group was treated with evolocumab combined with statin for lipid-lowering
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
drug2
Intervention Description
the control group was treated with statin only for lipid-lowering
Primary Outcome Measure Information:
Title
the main indicator
Description
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).
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
the secondary indicator
Description
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
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 50-75 years old, gender unlimited;
Diagnosed as coronary atherosclerotic heart disease
The informed consent for the study has been signed
Exclusion Criteria:
Those who are unable to cooperate with the examination;
Poor imaging quality of refractive interstitial opacity;
Macular edema or complicated with macular membrane and senile macular degeneration;
Have a history of previous fundus surgery;
Those with eye diseases that can cause changes in the microvessels of the fundus;
Abnormal elevated intraocular pressure;
Moderate or above refractive error (≥ ± 3 diopters)
People with cognitive impairment, material dependence, and serious mental illness;
Those who do not cooperate with follow-up;
Those who participate in other clinical trials at the same time
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyu Wang, Master
Phone
13181933930
Email
wxysd2021@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lifen Gao, Master
Facility Information:
Facility Name
Zibo Central Hospital
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyu Wang, Master
Phone
13181933930
Email
wxysd2021@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
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