Physicians International CT Utilization Registry 2

NCT ID: NCT02354196

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-02-28

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

CCTA

Subjects who underwent a CCTA

CCTA

Intervention Type: PROCEDURE

CT of heart to assess coronary disease

Interventions

CCTA

CT of heart to assess coronary disease

Intervention Type: PROCEDURE

Other Intervention Names

Cardiac CT Angiography

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• No prior CVD
• No hypertension
• No Diabetes
• Body mass index (BMI) <35 kg/m2.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MDDX LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MDDX

San Francisco, California, United States

FACTS

Hyderabad, , India

Countries

United States; India

Other Identifiers

Big PICTURE 2

Identifier Type: -

Identifier Source: org_study_id