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CompletedNCT03615963Updated Aug 28, 2018

Aortic Stiffness and Distensibility as Predictor to Severity of Coronary Artery Disease

An observational study in Coronary Artery Disease, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
Up to 70 Years
Sex
All
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Study summary

Assess the relationship of Aortic root distensibility and stiffness with the extent of coronary artery disease as assessed by SYNTAX score compared to a matched cohort of patients with normal coronary angiography

Read the detailed description

Cardiovascular disease leading cause of death, resulting in a number of annually deceased people higher than from any other. The great incidence of cardiovascular diseases in the world spurred the search for new solutions to enable an early detection of pathological processes The early detection based in multi-parameters of pathological condition is the key to the patient survival .The arterial stiffness is the first vessels modification, responsible for several pathological processes, which can lead to cardiovascular diseases.

The normal aging process is associated with an increase in vascular stiffness which is accelerated by atherosclerosis, hypertension, and diabetes mellitus. Several studies have revealed that increased aortic stiffness is a risk factor for cardiovascular diseases and also is a predictor of cardiovascular morbidity and mortality.

Interest in arterial stiffness waned in the early 1900s with the advent of the sphygmomanometer, which offered a quantitative measure of blood pressure and risk prediction .

Another factor is Aortic distensibility which is a measurement of vascular elasticity, and reflects the stiffness of the aorta . Aortic distensibility is markedly decreased in patients with known coronary artery disease . and is inversely proportional to the severity of Coronary artery disease .

Two-dimensional and tissue Doppler imaging derived parameters of ascending aorta have been found to be abnormal, indicating increased Aortic stiffness and impaired Aortic distensibility in subjects with coronary artery disease, hypertension, and diabetes mellitus. However, the direct correlation of Aortic stiffness with Coronary artery disease is hard to examine as most of these patients are old and have comorbidities such as hypertension, So Investigation of these parameters should be done in patients who are normotensive as most of these patients do not have confounding factors that increase Aortic stiffness.

Although the relationship between Aortic distensibility and Aortic stiffness and atherosclerosis is well known , the possible relation between them and the extent and complexity of coronary artery disease. as assessed using SYNTAX score has not been clearly determined yet.

The SYNTAX score is a lesion-based angiographic scoring system originally devised to grade the complexity of coronary artery disease.

. It is related to adverse cardiovascular events and predicts mortality and morbidity in patients with coronary artery disease.

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Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 150 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patient suspected to have coronary artery disease based on clinical date will underwent echocardiography to measure aortic root stiffness and elasticity then coronary angiography will be done to differentiate normal and coronary artery disease .

then aortic root stiffness and elasticity will be compared between the two groups.

is aortic root stiffness and elasticity can predict coronary artery disease and its severity

Inclusion criteria

  • all patients suspected to have coronary artery disease

Exclusion criteria

Exclusion Criteria:

  • -Hypertension( SBP>140mmhg or DBP>90mmhg)
  • Previous coronary stenting
  • Previous CABG
  • Renal diseases.
  • Decompensated liver disease.
  • Connective tissue diseases.
  • Aortic valve disease ( more than mild aortic stenosis or regurgitation)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • normal

    patient complains of anginal chest pain but coronary angiography is normal

    Diagnostic Test: echocardiography and coronary angiography

  • coronary artery disease

    patient complains of chest pain with coronary angiography showing atherosclerotic plaques causing luminal obstruction

    Diagnostic Test: echocardiography and coronary angiography

Interventions

  • Diagnostic testechocardiography and coronary angiography

    transthoracic echocardiography will be done for all subjects to measure aortic stiffness and elaticity then coronary angiography was used to differentiate between normal subjects and who have coronary artery disease

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What researchers measure

Primary outcomes

  1. compare aortic stiffness and elasticity in normal subjects and patient with coronary artery disease

    aortic stiffness by echocardiography ⊿P=Ps-Pd mmHg. ⊿D=As-Ad cm. local arterial stiffness can be calculated using the following formula: Aortic distensibility (AD) cm2/dyn= (2x⊿D)/((Adx⊿p)) Aortic stiffness index(SI)= ln (Ps/Pd)/(⊿D/Ad) no units ln is the natural logarithm Arterial strain = (⊿D)/Ad no units The elastic modulus E(p) = (⊿P)/Strain ( mmHg/cm) tissue doppler imaging (TDI) The TDI of expansion peak velocity during systole (SAo) and early (EAo) and late (AAo) diastolic peak velocities (m/s)are obtained then coronary angiography will be done to differentiate the 2 groups into normal and others have coronary artery disease using Syntax score( SS) Patients were divided into three tertiles: SS LOW ≤22 22\< SSMID ≤32 SS HIGH \>32

    Time frame: 1 hour

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Study locations

1 site
  • Helen Sami Anwar
    Assiut, Egypt
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References and documents

Publications

  • Wilkinson IB, Cockcroft JR, McEniery CM. Aortic stiffness as a cardiovascular risk predictor. BMJ. 2015 Jul 14;351:h3764. doi: 10.1136/bmj.h3764. No abstract available. PubMed 26173600 ↗
  • Wang F, Ye P, Luo L, Xiao W, Qi L, Bian S, Wu H, Sheng L, Xiao T, Xu R. Association of serum lipids with arterial stiffness in a population-based study in Beijing. Eur J Clin Invest. 2011 Sep;41(9):929-36. doi: 10.1111/j.1365-2362.2011.02481.x. Epub 2011 Feb 14. PubMed 21314825 ↗
  • Zhang YJ, Iqbal J, Campos CM, Klaveren DV, Bourantas CV, Dawkins KD, Banning AP, Escaned J, de Vries T, Morel MA, Farooq V, Onuma Y, Garcia-Garcia HM, Stone GW, Steyerberg EW, Mohr FW, Serruys PW. Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. J Am Coll Cardiol. 2014 Aug 5;64(5):423-32. doi: 10.1016/j.jacc.2014.05.022. PubMed 25082573 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03615963
Lead sponsor
Assiut University
Responsible party
HSAnwar (Principal investigator, Assiut University) — Principal investigator
First posted
Aug 6, 2018
Start date
Oct 1, 2017
Primary completion
Mar 31, 2018
Completion
Jun 1, 2018
Last update
Aug 28, 2018

Study contacts

Salwa Demitry
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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