An observational study in Coronary Artery Disease, sponsored by MDDX LLC. Withdrawn at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.
Sponsored by MDDX LLC · Observational
To determine the total plaque burden, plaque severity and composition of patients undergoing Cardiac CT who do not have any previous history of CVD. There are two cohorts:
In the original BIG PICTURE trial, the analysis of over 6000 subject's CCTA images found significant differences amongst patients of Arabic and south-east Asian descent, with regard to plaque burden, severity and composition. Due to the "all-comers" nature of that trial, the factors of diabetes, previous CVD, and other coronary risk factors were likely confounders in the results. In this trial, those subject selection is screened to eliminate those factors with the goal of working with a more homogenous population to perform the plaque analysis. This study is a multicenter, prospective, post marketing, observational registry study designed to describe frequency and patterns of various risk factors, indications and findings in patients who undergo CCTA.
BIG PICTURE 2 (abbreviated as "BP2") will collect data on patients from a wide variety of imaging sites (inpatient, outpatient, in-clinic CT machine). While the majority of the sites are within the US, the data collection will not be limited to US-only sites. A sub study of BP2 will perform a remote short follow-up questionnaire of subjects who were in the original Big PICTURE study.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
Browse Coronary Artery Disease studies →MDDX LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.
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1000 subjects, 18 or older, no previous CAD
Subject Inclusion Criteria
Subject Exclusion Criteria
Subjects who underwent a CCTA
Procedure: CCTA
CT of heart to assess coronary disease
Also known as: Cardiac CT Angiography
Plaque characteristics
Total plaque burden, composition, location, severity and myocardial perfusion deficits
Time frame: Immediately after scan
MACE endpoints
Standard MACE endpoints
Time frame: 2 years (or more)
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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