NCT02415452

Researches of Retinal Artery Lesions and Acute Coronary Syndrome

Retinal Artery Lesions to Predict Long-term Outcomes in Patients With Acute Coronary Syndrome After Drug-Eluting Stent Implantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 660 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the relationship between staging of retinal artery lesions and the prognosis of acute coronary syndrome (ACS) in a Chinese population. All the patients were divided into four groups according retinal artery lesions.The endpoints were main adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, myocardial infarction (MI), and stroke after 3 to 6 years of follow-up.

Detailed description

The aim of this study was to determine whether retinal artery lesions can predict long-term adverse outcomes in acute coronary syndrome (ACS) patients after drug-eluting stent (DES) implant. A total of 660 consecutive patients with ACS who underwent coronary angiography and percutaneous coronary intervention enrolled this study at the Beijing Mentougou District Hospital, Beijing Tiantan Hospital and Beijing Shijitan Hospital. All the subjects were divided into two groups based on the retinal artery lesions: Group 1, retinal artery lesions≤ Stage 2 (n=296) and group 2 (n=364), retinal artery lesions \> Stage 2. Beside,the eye fundus examination was done in all patients to mesure the extent and severity of atherosclerotic vascular lesions in the retinal arteries . Patients were excluded from the study if they had severe nephropathy (GFR\< 30 mL/min/1.73 m2), vascular obstruction, acute illnesses or any other condition that was thought to contraindicated coronary angiography. Primary endpoint was all-cause mortality. The composite endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE), namely recurrent serious angina pectoris, nonfatal MI, revascularization and stroke.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
PROCEDURE	drug-eluting stent implantation	The DES contains Firebird , sirolimus-eluting stents, paclitaxel-eluting stents , or zotarolimus-eluting stents . Unfractionated heparin was used during percutaneous coronary intervention .A loading dose of 300 mg clopidogrel was given to all patients prior to PCI, followed by a maintenance dose of 75 mg daily for 12 months before it was stopped.

Timeline

• Start date: 2006-07-01
• Primary completion: 2013-05-01
• Completion: 2018-01-01
• First posted: 2015-04-14
• Last updated: 2016-01-20