Physicians International CT Utilization Registry 2

Coronary Artery Disease Clinical Trial

— Big PICTURE 2  

Official title:

Big PICTURE 2: Physicians International CT Utilization Registry 2

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02354196
• Other study ID #: Big PICTURE 2
• Status: Withdrawn
• Phase: N/A
• First received: January 29, 2015
• Last updated: March 21, 2017
• Start date: May 2015
• Est. completion date: February 2017

Study information

• Verified date: September 2015
• Source: MDDX LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß blockers or nitroglycerin Strategies for Recruitment and Retention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• CCTA
CT of heart to assess coronary disease

Locations

Country	Name	City	State
India	FACTS	Hyderabad
United States	MDDX	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
MDDX LLC

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque characteristics	Total plaque burden, composition, location, severity and myocardial perfusion deficits	Immediately after scan
Secondary	MACE endpoints	Standard MACE endpoints	2 years (or more)