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Multi-slice CT Coronary Angiography in Patients With Stable Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963609
Recruitment Status : Completed
First Posted : May 24, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
shaimaa Mostafa, Benha University

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 24, 2019
Last Update Posted Date May 28, 2019
Actual Study Start Date January 1, 2016
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019)
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
Original Primary Outcome Measures
 (submitted: May 23, 2019)
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
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-slice CT Coronary Angiography in Patients With Stable Angina
Official Title Multi-slice CT Coronary Angiography Assessment of Remodeling Index in Patients With Low to Intermediate Risk Stable Angina
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Stable Angina
Intervention Radiation: multisclice CT
assessment of the remodeling index by multisclice CT in patients with chronic stable angina
Study Groups/Cohorts Not Provided
Publications * Mostafa SA, Aboelazem T, Sanad O, Abdelghafar H, Azam A. Multi-slice CT coronary angiography assessment of remodeling index in patients with low- to intermediate-risk stable angina. Egypt Heart J. 2019 Sep 11;71(1):7. doi: 10.1186/s43044-019-0011-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 23, 2019)
150
Original Actual Enrollment Same as current
Actual Study Completion Date March 1, 2018
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03963609
Other Study ID Numbers 1258ase
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party shaimaa Mostafa, Benha University
Study Sponsor Benha University
Collaborators Not Provided
Investigators Not Provided
PRS Account Benha University
Verification Date May 2019