Researches of Retinal Artery Lesions and Acute Coronary Syndrome

NCT ID: NCT02415452

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Acute Coronary Syndrome (ACS) patients

Acute coronary syndrome (ACS) patients who underwent coronary angiography ,drug-eluting stent (DES) implantation, and eye fundus examination.

drug-eluting stent implantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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DES

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Mentougou District Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Buxing Chen

Beijing Tiantan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Reference Type RESULT
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Reference Type RESULT
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Wu Y, Li S, Zu X, Du J, Wang F. Changes of central retinal artery blood flow and endothelial function in patients with coronary artery disease. Curr Eye Res. 2007 Sep;32(9):813-7. doi: 10.1080/02713680701572664.

Reference Type RESULT
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Other Identifiers

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REACS

Identifier Type: -

Identifier Source: org_study_id

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