NCT02354196

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. 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. 2.A prospective observational registry of patients referred to undergo CCTA with a 1 and 2 year follow-up.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

January 29, 2015

Last Update Submit

March 21, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Plaque characteristics

    Total plaque burden, composition, location, severity and myocardial perfusion deficits

    Immediately after scan

Secondary Outcomes (1)

  • MACE endpoints

    2 years (or more)

Study Arms (1)

CCTA

Subjects who underwent a CCTA

Procedure: CCTA

Interventions

CCTAPROCEDURE

CT of heart to assess coronary disease

Also known as: Cardiac CT Angiography
CCTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1000 subjects, 18 or older, no previous CAD

You may qualify if:

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

You may not qualify if:

  • \<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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MDDX

San Francisco, California, 94111, United States

Location

FACTS

Hyderabad, India

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 22, 2017

Record last verified: 2015-09

Locations

US(1)IN(1)