NCT03615963

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

July 5, 2018

Last Update Submit

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

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

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

coronary artery diseasenormal

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Location

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: 26173600BACKGROUND
  • 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.

    PMID: 21314825BACKGROUND
  • 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.

    PMID: 25082573BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

EchocardiographyCoronary Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularAngiographyRadiography

Study Officials

  • Salwa Demitry

    Assiut University

    STUDY DIRECTOR

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

Locations