Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331370
Status:
UNKNOWN
Last Update Posted:
2006-05-31
First Post:
2006-05-30
Brief Title:
Hypertension Related Damage to the Microcirculation in South Asian Emergence Predictive Power and Reversibility
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Hypertension Related Damage to the Microcirculation in South Asian EmergencePredictive Power and Reversibility
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Damage to very small blood vessels is a consequence but can also precede high blood pressure Such damage measured by disturbances in the vessels in the retina back of the eye is a strong predictor of heart disease and stroke South Asian people have one of the highest rates of hypertension in the world 30 in adults In Pakistan this is usually severe undetected and untreated The Wellcome Trust has already funded a study of blood pressure control in adults and children in this population We propose a substudy taking photographs of the retina and making measurements of the vessels to determine whether such blood pressure related changes occur at an early age in young children with a family history of high blood pressure compared to those without whether such changes predict an increase in blood pressure over time and whether in adults such changes can be reversed by blood pressure treatment The hypothesis of our study is young offspring of South Asian people with hypertension have a disturbed microcirculation as assessed by abnormalities of retinal vessels compared to offspring of normotensive parents Our 2nd hypothesis is Abnormal retinal vascular geometry will improve proportionately to achieved reductions in BP
Detailed Description:
Background
The role of the microcirculation is increasingly being recognized in the etiopathogenesis of cardiovascular disease Delays in this recognition are in part due to the difficulty of studying the microcirculation non-invasively in large numbers of individuals Retinal vessels provide an easily accessible window to the microcirculation Abnormalities of the retinal vasculature have been shown to be associated with cardiovascular risk factors and all cause mortality Non-invasive assessment of the retinal circulation presents a valuable opportunity to study the structure and function of the microvasculature
Aims of the project
To compare geometry of retinal microvasculature of 1 hypertensive vs normotensive adults 2 children aged 10 to 14 years of hypertensive parent test group versus normotensive parent control group and 3 to assess the impact of blood pressure lowering on these changes over 2 years
Primary outcome would be abnormal retinal geometry defined as the composite outcome of a abnormal arteriolar length diameter ratios a measure of relative arteriolar narrowing b narrowed branching angles an indicator of arteriolar rarefaction or c disturbed junction exponents a marker of endothelial dysfunction
Significance of the study
If successful this work could be extended to address future questions including the predictive value of these abnormalities for development of diabetes and hypertension as well as CVD to explore further the role of microvascular disturbances in disease etiology and to assess the impact of drug therapy on these abnormalities and their relationship to outcomes in the South Asian population
The role of the microcirculation is increasingly being recognized in the etiopathogenesis of cardiovascular disease Delays in this recognition are in part due to the difficulty of studying the microcirculation non-invasively in large numbers of individuals Retinal vessels provide an easily accessible window to the microcirculation Abnormalities of the retinal vasculature have been shown to be associated with cardiovascular risk factors and all cause mortality Non-invasive assessment of the retinal circulation presents a valuable opportunity to study the structure and function of the microvasculature
Aims of the project
To compare geometry of retinal microvasculature of 1 hypertensive vs normotensive adults 2 children aged 10 to 14 years of hypertensive parent test group versus normotensive parent control group and 3 to assess the impact of blood pressure lowering on these changes over 2 years
Primary outcome would be abnormal retinal geometry defined as the composite outcome of a abnormal arteriolar length diameter ratios a measure of relative arteriolar narrowing b narrowed branching angles an indicator of arteriolar rarefaction or c disturbed junction exponents a marker of endothelial dysfunction
Significance of the study
If successful this work could be extended to address future questions including the predictive value of these abnormalities for development of diabetes and hypertension as well as CVD to explore further the role of microvascular disturbances in disease etiology and to assess the impact of drug therapy on these abnormalities and their relationship to outcomes in the South Asian population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None