Chronic Stable Angina Clinical Trial
Official title:
Multi-slice CT Coronary Angiography Assessment of Remodeling Index in Patients With Low to Intermediate Risk Stable Angina
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 |
Verified date | May 2019 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Benha University |
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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