Physicians International CT Utilization Registry 2 (Big PICTURE 2)

March 21, 2017 updated by: MDDX LLC

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, India
        • FACTS
  • United States
    • California
      • San Francisco, California, United States, 94111
        • MDDX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1000 subjects, 18 or older, no previous CAD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CCTA
Subjects who underwent a CCTA
Procedure: CCTA
CT of heart to assess coronary disease
Other Names:
  • Cardiac CT Angiography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDDX LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Big PICTURE 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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