Coronary Artery DiseaseNCT03615963
Aortic Stiffness and Distensibility as Predictor to Severity of Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- echocardiography and coronary angiography
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- all patients suspected to have coronary artery disease
Who cannot join
- -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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Root Distensibility And Stiffness Assessed By Echocardiography As Predictors Of Coronary Artery Lesion Severity In Coronary Artery Patients Undergoing Coronary Angiography
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.
- Conditions
- Coronary Artery Disease
- Being tested
- echocardiography and coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography and coronary angiographyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| normal | patient complains of anginal chest pain but coronary angiography is normal Receives: Diagnostic Test: echocardiography and coronary angiography | |
| coronary artery disease | patient complains of chest pain with coronary angiography showing atherosclerotic plaques causing luminal obstruction Receives: Diagnostic Test: echocardiography and coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2017
- Primary completion31 Mar 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSAnwar, Assiut University
- Investigators
- Salwa Demitry, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615963
- Sponsor's protocol ID
- Aortic stiffness
- Status last verified
- Aug 2018
- First submitted
- 5 Jul 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 26173600Wang 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 21314825Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Root Distensibility And Stiffness Assessed By Echocardiography As Predictors Of Coronary Artery Lesion Severity In Coronary Artery Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT03615963
- Acronym / sponsor ID
- Aortic stiffness
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal | – | Diagnostic Test: echocardiography and coronary angiographypatient complains of anginal chest pain but coronary angiography is normal |
| coronary artery disease | – | Diagnostic Test: echocardiography and coronary angiographypatient complains of chest pain with coronary angiography showing atherosclerotic plaques causing luminal obstruction |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- all patients suspected to have coronary artery disease
Key exclusion criteria (7 listed)
- -Hypertension( SBP>140mmhg or DBP>90mmhg)
- Previous coronary stenting
- Previous CABG
- Renal diseases.
- Decompensated liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography and coronary angiographytransthoracic 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 | Diagnostic test | coronary artery disease, normal |
Primary outcome
compare aortic stiffness and elasticity in normal subjects and patient with coronary artery disease
Time frame: 1 hour
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 26173600Wilkinson 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.
- Background: PubMed 21314825Wang 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.
- Background: PubMed 25082573Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa Demitry study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare aortic stiffness and elasticity in normal subjects and patient with coronary artery disease (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.