Physicians International CT Utilization Registry 2

Study Overview
=================
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: 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. 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.

Official Title
-----------------
Big PICTURE 2: Physicians International CT Utilization Registry 2

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: CCTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject Inclusion Criteria 18 years or older No prior CVD No hypertension No Diabetes Body mass index (BMI) <35 kg/m2. Subject Exclusion Criteria <18 years or older Prior CVD Hypertension Body mass index (BMI) >=30 kg/m2. Diabetes Mellitus Type 1 or 2 Current or previous history of smoking Pregnancy Planned intervention or bypass surgery Known complex congenital heart disease Planned invasive angiography for reasons other than CAD Non-cardiac illness with life expectancy < 2 years Inability to provide written informed consent Concomitant participation in another clinical trial in which subject is subject to investigational drug or device Pregnant women Allergy to iodinated contrast agent Serum creatinine >1.5 mg/dl or GFR <30 ml/min Baseline irregular heart rhythm Heart rate ≥100 beats per minute Systolic blood pressure ≤90 mm Hg Contraindications to β blockers or nitroglycerin Strategies for Recruitment and Retention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CCTA<br>Subjects who underwent a CCTA | Procedure: CCTA<br>* CT of heart to assess coronary disease<br>* Other names: Cardiac CT Angiography;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque characteristics | Total plaque burden, composition, location, severity and myocardial perfusion deficits | Immediately after scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE endpoints | Standard MACE endpoints | 2 years (or more) |