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- Ensayo clínico NCT02415452
Researches of Retinal Artery Lesions and Acute Coronary Syndrome (REACS)
Retinal Artery Lesions to Predict Long-term Outcomes in Patients With Acute Coronary Syndrome After Drug-Eluting Stent Implantation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
- acs patients in beijing mentougou district hospital
- acs patients in beijing shijitan hospital
- acs patients in beijing tiantan hospital
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Acute Coronary Syndrome (ACS) patients
Acute coronary syndrome (ACS) patients who underwent coronary angiography ,drug-eluting stent (DES) implantation, and eye fundus examination.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Main cardiac events
Periodo de tiempo: July 1, 2006 to December 31, 2015, up to 9 years
|
recurrent serious angina pectoris, nonfatal MI, revascularization and stroke
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July 1, 2006 to December 31, 2015, up to 9 years
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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. doi: 10.1093/oxfordjournals.aje.a009997.
- 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. doi: 10.1016/j.amjcard.2005.05.070. Epub 2005 Aug 29.
- 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. doi: 10.1016/j.jacc.2007.03.029. Epub 2007 Jun 18.
- 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. doi: 10.1161/01.atv.20.6.1644.
- SCHEIE HG. Evaluation of ophthalmoscopic changes of hypertension and arteriolar sclerosis. AMA Arch Ophthalmol. 1953 Feb;49(2):117-38. doi: 10.1001/archopht.1953.00920020122001. No abstract available.
- 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 adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009 Jan;32(1):193-203. doi: 10.2337/dc08-9025. Epub 2008 Oct 22.
- 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. doi: 10.1016/j.ophtha.2005.12.013.
- 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. doi: 10.1016/j.ajo.2005.08.063.
- 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. doi: 10.1016/0002-8703(75)90325-7.
- 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. doi: 10.1001/jama.287.9.1153.
- 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. doi: 10.1161/HYPERTENSIONAHA.107.098343. Epub 2007 Nov 12.
- Wang DZ, Tang Q, Hua Q. Prediction of coronary artery disease using pulse wave velocity and retinal artery lesions. Tohoku J Exp Med. 2011 Sep;225(1):17-22. doi: 10.1620/tjem.225.17.
- 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. doi: 10.1001/jama.288.1.67.
- 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. doi: 10.1001/jama.293.1.63.
- 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. doi: 10.1161/01.HYP.0000140772.40322.ec. Epub 2004 Aug 9.
- 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. doi: 10.1161/01.HYP.0000199104.61945.33. Epub 2005 Dec 27.
- 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. doi: 10.1038/oby.2006.27.
- 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. doi: 10.1161/01.cir.81.5.1586.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REACS
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