Automatic Image Analyzer to Assess Retinal Vessel Caliber

NCT02087605 | Completed

• 1 other identifier: C2013
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this work is the development and validation (reliability and validity) of the Automatic image analyzer to assess it retinal vessel caliber (ALTAIR) platform to analyze and validate its utility in different clinical settings. Methods / Design Design : In the first phase , will be a cross- sectional study and a second phase will be a prospective observational study with annual follow-up for 4 years. The study will be conducted in primary care including 386 subjects. Main measurements: blood pressure, carotid intima-media thickness using carotid ultrasound , central blood pressure and wave velocity pulse by SphygmoCor system, Cardio-ankle vascular index (CAVI) by VASERA® VS1500 , evaluation of hypertrophy ventricular using a digital ECG and renal injury . Retinal vascular evaluation will be done by a non-mydriatic TOPCON TRCNW200 getting focused papilla, nasal and temporal and developed by software images automatically calculate the thickness of the retinal vessels , the arteriovenous index, the vascularized area and branching pattern . For validation software retina intra and inter - observer variability , the correlation of the tool measurement with AVindex , and concurrent validity with parameters of vascular structure and function and target organ damage and association analysis will analyze the different parameters of the estimated retina and evolution or appearance of new lesions in the target organs. Discussion The validation of the tool contribute to the analysis of retinal vessels improved reliability by reducing the intervention of the observer and further validate the use of more information than the previously used , especially surface vascularization and vessel branching patterns .

Conditions

Cardiovascular Risk Factor

Keywords

Vascular stiffness, retinal vessels, target organ damage

Outcome Measures

Primary Outcomes (1)

• Thickness, surface and branching vessels of the retina

  Thickness, surface and branching vessels of the retina evaluate by ALTAIR and AV index for two investigators

  Up to eight mounths

Secondary Outcomes (1)

• Arterial stiffness

  Up to five years

Other Outcomes (1)

• Number patients with cardiovascular disease

  Up to five years

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

386 subjets of 30 to 75 years

You may qualify if:

• Some cardiovascular risk factor following the 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension

You may not qualify if:

• Psychological and / or cognitive impairment, no partners, educational and understanding limitations and severe comorbidity that would endanger his life in the next 12 months

Sponsors & Collaborators

• Fundacion para la Investigacion y Formacion en Ciencias de la Salud: lead
• University of Salamanca: collaborator

Study Sites (1)

Primary care research unit La Alamedilla

Salamanca, Salamanca, 37003, Spain

Location

Related Publications (2)

• Garcia-Ortiz L, Recio-Rodriguez JI, Parra-Sanchez J, Gonzalez Elena LJ, Patino-Alonso MC, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA; Vaso-risk group. A new tool to assess retinal vessel caliber. Reliability and validity of measures and their relationship with cardiovascular risk. J Hypertens. 2012 Apr;30(4):770-7. doi: 10.1097/HJH.0b013e3283506628.

  PMID: 22306849 RESULT

• Garcia-Ortiz L, Gomez-Marcos MA, Recio-Rodriguez JI, Maderuelo-Fernandez JA, Chamoso-Santos P, Rodriguez-Gonzalez S, de Paz-Santana JF, Merchan-Cifuentes MA, Corchado-Rodriguez JM; ALTAIR group. Validation of the automatic image analyser to assess retinal vessel calibre (ALTAIR): a prospective study protocol. BMJ Open. 2014 Dec 2;4(12):e006144. doi: 10.1136/bmjopen-2014-006144.

  PMID: 25468505 DERIVED

Study Officials

• Juan M Corchado, PhD

  University of Salamanca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 14, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

ES (1)