Aortic Stiffness and Distensibility as Predictor to Severity of Coronary Artery Disease
Aortic Root Distensibility And Stiffness Assessed By Echocardiography As Predictors Of Coronary Artery Lesion Severity In Coronary Artery Patients Undergoing Coronary Angiography
1 other identifier
observational
150
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 5, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedAugust 28, 2018
August 1, 2018
6 months
July 5, 2018
August 26, 2018
Conditions
Outcome Measures
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
1 hour
Study Arms (2)
normal
patient complains of anginal chest pain but coronary angiography is normal
coronary artery disease
patient complains of chest pain with coronary angiography showing atherosclerotic plaques causing luminal obstruction
Interventions
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
Eligibility Criteria
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
You may qualify if:
- all patients suspected to have coronary artery disease
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helen Sami Anwar
Asyut, Egypt
Related Publications (3)
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.
PMID: 26173600BACKGROUNDWang 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.
PMID: 21314825BACKGROUNDZhang 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.
PMID: 25082573BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Salwa Demitry
Assiut University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 5, 2018
First Posted
August 6, 2018
Study Start
October 1, 2017
Primary Completion
March 31, 2018
Study Completion
June 1, 2018
Last Updated
August 28, 2018
Record last verified: 2018-08