NCT02354196

Physicians International CT Utilization Registry 2

Big PICTURE 2: Physicians International CT Utilization Registry 2

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: MDDX LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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: 1. A retrospective follow-up for MACE endpoints of patients who underwent a CCTA \>1 year ago as part of the Big PICTURE Trial, who meet the inclusion criteria of Big PICTURE 2. 2. A prospective observational registry of patients referred to undergo CCTA with a 1 and 2 year follow-up.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	CCTA	CT of heart to assess coronary disease

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-02-03
• Last updated: 2017-03-22

Locations

2 sites across 2 countries: United States, India