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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03963609
Other study ID # 1258ase
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date March 1, 2018

Study information

Verified date May 2019
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

early identification of vulnerable plaques by remodeling index prior to rupture and development of acute event is of considerable importance especially by a reliable non-invasive method as CT coronary angiography.


Description:

single-center, cross section, observational study included 150 patients with stable angina with normal resting ECG, negative markers, normal systolic function by 2D echocardiography (EF>50%) and without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 1, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- first attack, low to intermediate risk stable angina

- normal resting ECG,

- negative markers

- normal systolic function by 2D echocardiography (EF>50%)

- without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Exclusion Criteria:

- previous acute coronary syndrome or revascularization, those with renal impairment or dye hypersensitivity, patients with morbid obesity (BMI>40kg/m²), rhythm other than sinus rhythm inability to hold breath for 10sec to acquire the image lesions with heavy calcium score.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
multisclice CT
assessment of the remodeling index by multisclice CT in patients with chronic stable angina

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Outcome

Type Measure Description Time frame Safety issue
Primary remodeling of the coronary artery to study the changes in wall of the arteries in patients with chronic stable angina early changes don't appear in coronary angiography as it occurs in the form of positive remodeling which can be detected by multisclice coronary angiography Remodeling index is defined as the ratio of the maximum vessel area (or diameter) to a normal reference vessel area (or diameter), and plaques are classified as having significant positive remodeling when the remodeling index is >1.1 2 years
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