Coronary Artery DiseaseBig PICTURE 2NCT02354196
Physicians International CT Utilization Registry 2
An observational study of Coronary Artery Disease, run by MDDX LLC at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CCTA
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2015to Feb 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 subjects, 18 or older, no previous CAD
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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:
- 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.
- A prospective observational registry of patients referred to undergo CCTA with a 1 and 2 year follow-up.
Read the 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
- Being tested
- CCTA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTAProcedure or surgery
Also called Cardiac CT Angiography
CT of heart to assess coronary disease
| Study group | Role | What they receive |
|---|---|---|
| CCTA | Subjects who underwent a CCTA Receives: Procedure: CCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque characteristics
Total plaque burden, composition, location, severity and myocardial perfusion deficits
Measured: Immediately after scan
Secondary outcomes (1)
MACE endpoints
Standard MACE endpoints
Measured: 2 years (or more)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- MDDX LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354196
- Sponsor's protocol ID
- Big PICTURE 2
- Acronym
- Big PICTURE 2
- Status last verified
- Sep 2015
- First submitted
- 29 Jan 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big PICTURE 2: Physicians International CT Utilization Registry 2
- ClinicalTrials.gov ID
- NCT02354196
- Acronym / sponsor ID
- Big PICTURE 2 / Big PICTURE 2
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MDDX LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA | – | Procedure: CCTASubjects who underwent a CCTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 subjects, 18 or older, no previous CAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTAAlso: Cardiac CT AngiographyCT of heart to assess coronary disease | Procedure or surgery | CCTA |
Primary outcome
Plaque characteristics
Time frame: Immediately after scan
Total plaque burden, composition, location, severity and myocardial perfusion deficits
1 secondary outcome
MACE endpoints
Time frame: 2 years (or more)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by MDDX LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque characteristics (time frame: Immediately after scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.