Researches of Retinal Artery Lesions and Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— REACS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02415452
• Other study ID #: REACS
• Status: Active, not recruiting
• Phase: N/A
• First received: April 9, 2015
• Last updated: January 16, 2016
• Start date: July 2006
• Est. completion date: January 2018

Study information

• Verified date: January 2016
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Beijing municipal commission of science and technology,Beijing:China.
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 660
• Est. completion date: January 2018
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Haidian Hospital, Beijing Mentougou District Hospital, Beijing Shijitan Hospital

References & Publications (19)

Cheung N, Bluemke DA, Klein R, Sharrett AR, Islam FM, Cotch MF, Klein BE, Criqui MH, Wong TY. Retinal arteriolar narrowing and left ventricular remodeling: the multi-ethnic study of atherosclerosis. J Am Coll Cardiol. 2007 Jul 3;50(1):48-55. Epub 2007 Jun — View Citation

Ikram MK, Witteman JC, Vingerling JR, Breteler MM, Hofman A, de Jong PT. Retinal vessel diameters and risk of hypertension: the Rotterdam Study. Hypertension. 2006 Feb;47(2):189-94. Epub 2005 Dec 27. — View Citation

Klein R, Klein BE, Knudtson MD, Wong TY, Cotch MF, Liu K, Burke G, Saad MF, Jacobs DR Jr. Prevalence of age-related macular degeneration in 4 racial/ethnic groups in the multi-ethnic study of atherosclerosis. Ophthalmology. 2006 Mar;113(3):373-80. — View Citation

Klein R, Sharrett AR, Klein BE, Chambless LE, Cooper LS, Hubbard LD, Evans G. Are retinal arteriolar abnormalities related to atherosclerosis?: The Atherosclerosis Risk in Communities Study. Arterioscler Thromb Vasc Biol. 2000 Jun;20(6):1644-50. — View Citation

Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B; American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and — View Citation

SCHEIE HG. Evaluation of ophthalmoscopic changes of hypertension and arteriolar sclerosis. AMA Arch Ophthalmol. 1953 Feb;49(2):117-38. — View Citation

Sellke FW, Armstrong ML, Harrison DG. Endothelium-dependent vascular relaxation is abnormal in the coronary microcirculation of atherosclerotic primates. Circulation. 1990 May;81(5):1586-93. — View Citation

Shah A, Gnoj J, Fisher VJ. Complications of selective coronary arteriography by the Judkins technique and their prevention. Am Heart J. 1975 Sep;90(3):353-9. — View Citation

Sharrett AR, Hubbard LD, Cooper LS, Sorlie PD, Brothers RJ, Nieto FJ, Pinsky JL, Klein R. Retinal arteriolar diameters and elevated blood pressure: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 1999 Aug 1;150(3):263-70. — View Citation

Smith W, Wang JJ, Wong TY, Rochtchina E, Klein R, Leeder SR, Mitchell P. Retinal arteriolar narrowing is associated with 5-year incident severe hypertension: the Blue Mountains Eye Study. Hypertension. 2004 Oct;44(4):442-7. Epub 2004 Aug 9. — View Citation

Tedeschi-Reiner E, Strozzi M, Skoric B, Reiner Z. Relation of atherosclerotic changes in retinal arteries to the extent of coronary artery disease. Am J Cardiol. 2005 Oct 15;96(8):1107-9. Epub 2005 Aug 29. — View Citation

Wang DZ, Tang Q, Hua Q. Prediction of coronary artery disease using pulse wave velocity and retinal artery lesions. Tohoku J Exp Med. 2011;225(1):17-22. — View Citation

Wang JJ, Taylor B, Wong TY, Chua B, Rochtchina E, Klein R, Mitchell P. Retinal vessel diameters and obesity: a population-based study in older persons. Obesity (Silver Spring). 2006 Feb;14(2):206-14. — View Citation

Wang L, Wong TY, Sharrett AR, Klein R, Folsom AR, Jerosch-Herold M. Relationship between retinal arteriolar narrowing and myocardial perfusion: multi-ethnic study of atherosclerosis. Hypertension. 2008 Jan;51(1):119-26. Epub 2007 Nov 12. — View Citation

Wong TY, Klein R, Islam FM, Cotch MF, Folsom AR, Klein BE, Sharrett AR, Shea S. Diabetic retinopathy in a multi-ethnic cohort in the United States. Am J Ophthalmol. 2006 Mar;141(3):446-455. — View Citation

Wong TY, Klein R, Sharrett AR, Couper DJ, Klein BE, Liao DP, Hubbard LD, Mosley TH; ARIC Investigators. Atheroslerosis Risk in Communities Study. Cerebral white matter lesions, retinopathy, and incident clinical stroke. JAMA. 2002 Jul 3;288(1):67-74. — View Citation

Wong TY, Klein R, Sharrett AR, Duncan BB, Couper DJ, Tielsch JM, Klein BE, Hubbard LD. Retinal arteriolar narrowing and risk of coronary heart disease in men and women. The Atherosclerosis Risk in Communities Study. JAMA. 2002 Mar 6;287(9):1153-9. — View Citation

Wong TY, Rosamond W, Chang PP, Couper DJ, Sharrett AR, Hubbard LD, Folsom AR, Klein R. Retinopathy and risk of congestive heart failure. JAMA. 2005 Jan 5;293(1):63-9. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main cardiac events	recurrent serious angina pectoris, nonfatal MI, revascularization and stroke	July 1, 2006 to December 31, 2015, up to 9 years	Yes