Researches of Retinal Artery Lesions and Acute Coronary Syndrome (REACS)

January 16, 2016 updated by: Buxing Chen, Capital Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

660

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Coronary Syndrome (ACS) patients
Acute coronary syndrome (ACS) patients who underwent coronary angiography ,drug-eluting stent (DES) implantation, and eye fundus examination.
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.
Other Names:
  • DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main cardiac events
Time Frame: July 1, 2006 to December 31, 2015, up to 9 years
recurrent serious angina pectoris, nonfatal MI, revascularization and stroke
July 1, 2006 to December 31, 2015, up to 9 years

Collaborators and Investigators

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

Sponsor

Capital Medical University

Collaborators

Beijing Shijitan Hospital, Capital Medical University
Beijing Haidian Hospital
Beijing Mentougou District Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2006

Primary Completion (Actual)

May 1, 2013

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 16, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REACS

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.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on drug-eluting stent implantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe