Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy

March 24, 2023 updated by: Bo Li, Zibo Central Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lifen Gao, Master

Study Locations

  • China
    • Shandong
      • Zibo, Shandong, China, 255000
        • Recruiting
        • Zibo Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
evolocumab combined with statins
Drug: Evolocumab combined with statins
The experimental group was treated with evolocumab combined with statin for lipid-lowering
Other Names:
  • drug1
Other: Control Group
statins only
Drug: Statin
the control group was treated with statin only for lipid-lowering
Other Names:
  • drug2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the main indicator
Time Frame: 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).
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the secondary indicator
Time Frame: 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
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zibo Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZiboCH2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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