Physicians International CT Utilization Registry 2

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Procedure: CCTA

• Registration Number: NCT02354196
• Lead Sponsor: MDDX LLC

Brief 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.

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Study Start: 2015-05
• Status Verified: 2015-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCTA	CCTA	Subjects who underwent a CCTA

Primary Outcome Measures

Name	Time	Method
Plaque characteristics	Immediately after scan	Total plaque burden, composition, location, severity and myocardial perfusion deficits

Secondary Outcome Measures

Name	Time	Method
MACE endpoints	2 years (or more)	Standard MACE endpoints

Trial Locations

Locations (2)

FACTS; 🇮🇳 Hyderabad, India

MDDX; 🇺🇸 San Francisco, California, United States