Clinical trial NCT02354196: Physicians International CT Utilization Registry 2
Official title: Big PICTURE 2: Physicians International CT Utilization Registry 2
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Lead sponsor: MDDX LLC
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 subjects, 18 or older, no previous CAD

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.

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

Primary outcomes:
measure: Plaque characteristics
timeFrame: Immediately after scan
Secondary outcomes:
measure: MACE endpoints
timeFrame: 2 years (or more)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: MDDX
state: California
city: Hyderabad
country: India
facility: FACTS
Study officials:
References: