Multi-slice CT Coronary Angiography in Patients With Stable Angina

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03963609
• Collaborator: (none)
• Enrollment: 150
• Actual Duration (Months): 26

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Stable Angina	Radiation: multisclice CT

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Multi-slice CT Coronary Angiography Assessment of Remodeling Index in Patients With Low to Intermediate Risk Stable Angina
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Mar 1, 2018

Outcome Measures

Primary Outcome Measures

1. remodeling of the coronary artery [2 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: shaimaa Mostafa, assistant professor, Benha University
• ClinicalTrials.gov Identifier: NCT03963609
• Other Study ID Numbers: 1258ase
• First Posted: May 24, 2019
• Last Update Posted: May 28, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by shaimaa Mostafa, assistant professor, Benha University: chronic stable angina; multislice CT; remodeling index
• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable

Study Results

No Results Posted as of May 28, 2019