NCT03963609

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

May 21, 2019

Last Update Submit

May 23, 2019

Conditions

Keywords

chronic stable anginamultislice CTremodeling index

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

evaluation of coronary artery remodeling index in patients with low to intermediate risk stable angina by MSCT coronary angiography.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 24, 2019

Study Start

January 1, 2016

Primary Completion

January 30, 2018

Study Completion

March 1, 2018

Last Updated

May 28, 2019

Record last verified: 2019-05