Physicians International CT Utilization Registry 2
| Status: | Withdrawn |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2017 |
| Start Date: | May 2015 |
| End Date: | February 2017 |
Big PICTURE 2: Physicians International CT Utilization Registry 2
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.
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.
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.
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.
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
We found this trial at
2
sites
