NCT04111198

Brief Summary

correlation between EFT volume measured by Cardiac MRI and the angiographic severity of coronary artery disease (Syntax Score) in diabetic vs non diabetic CAD population and detect if there is a cut off value for each group that could predict higher risk.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

September 29, 2019

Last Update Submit

September 30, 2019

Conditions

Epicardial Fat Tissue

Keywords

Epicardial fat tissueCardiac MRICoronary Artery disease

Outcome Measures

Primary Outcomes (1)

  • correlation between EFT volume measured by Cardiac MRI and the angiographic severity of coronary artery disease (Syntax Score) in diabetic vs non diabetic CAD population

    30 minutes

Study Arms (1)

coronary artery disease in diabetic and non diabetic patients

Radiation: Cardiac MRI

Interventions

Cardiac MRIRADIATION

Cardiac MRI

coronary artery disease in diabetic and non diabetic patients

Eligibility Criteria

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

Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.

You may qualify if:

  • Age over 18 years
  • Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.
  • Having diagnostic coronary angiography done or to be done within a 3 months of the cardiac MRI study

You may not qualify if:

  • patients not having CA within the aforementioned time limits. Other classical contraindications of cardiac MRI including: MRI non-conditional devices, claustrophobia and eGFR\> 30 ml/sec/1.73 m2 BSA. (NB. Gadolinium is not required for EFT measurement but for the viability study of the patients.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bakeer Mohamed Bakeer, MSC

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatem Abd Elrhman Helmy, Professor

CONTACT

01005212162hatem19652007@yahoo.com

Shimaa Sayed Khidr, lecturer

CONTACT

01001346551shaimaakhidr@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 1, 2019

Study Start

December 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

October 1, 2019

Record last verified: 2019-09