Clinical trial NCT02415452: Researches of Retinal Artery Lesions and Acute Coronary Syndrome
Official title: Retinal Artery Lesions to Predict Long-term Outcomes in Patients With Acute Coronary Syndrome After Drug-Eluting Stent Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: relationship
retinal artery lesions
long-term outcomes
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Mentougou District Hospital
name: Beijing Haidian Hospital
name: Beijing Shijitan Hospital, Capital Medical University
First posted: 2015-04-14
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. acs patients in beijing mentougou district hospital
2. acs patients in beijing shijitan hospital
3. acs patients in beijing tiantan hospital

Brief 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.

Eligibility criteria: Inclusion Criteria:

* consecutive patients with ACS who performed coronary angiography (CAG) and percutaneous coronary intervention (PCI).

Exclusion Criteria:

* Patients were excluded from the study if they had heart failure, malignancies, renal insufficiency (creatinine \> 133µmol/L), liver disease, stroke and severe lung disease.

Primary outcomes:
measure: Main cardiac events
timeFrame: July 1, 2006 to December 31, 2015, up to 9 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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