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Multi-slice CT Coronary Angiography in Patients With Stable Angina

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ClinicalTrials.gov Identifier: NCT03963609
Recruitment Status : Completed
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
shaimaa Mostafa, Benha University

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
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.

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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 : January 1, 2016
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina


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


Primary Outcome Measures :
  1. remodeling of the coronary artery [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
evaluation of coronary artery remodeling index in patients with low to intermediate risk stable angina by MSCT coronary angiography.
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: shaimaa Mostafa, assistant professor, Benha University
ClinicalTrials.gov Identifier: NCT03963609     History of Changes
Other Study ID Numbers: 1258ase
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by shaimaa Mostafa, Benha University:
chronic stable angina
multislice CT
remodeling index
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms