NCT01810198

Brief Summary

To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,631

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
6 countries

13 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

3.1 years

First QC Date

February 22, 2013

Last Update Submit

March 21, 2017

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseCardiac CTCatheterization

Outcome Measures

Primary Outcomes (1)

  • MACE Endpoints

    * Death * Non-fatal myocardial infarction * Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive) * Stroke * Urgent or emergent coronary revascularization * Cardiovascular hospitalization (including for angina, heart failure or other)

    1 year

Secondary Outcomes (1)

  • Additional MACE Endpoints

    1 year

Other Outcomes (3)

  • Economic

    1 year

  • Secondary Safety Endpoint

    1 year

  • Quality of Life

    1 year

Study Arms (2)

Cardiac CT

ACTIVE COMPARATOR

Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)

Procedure: Cardiac CT

Invasive Coronary Angiography

ACTIVE COMPARATOR

Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography

Procedure: Invasive Coronary Angiography

Interventions

Cardiac CTPROCEDURE

Perform a non-invasive Cardiac CT Angiogram

Cardiac CT
Invasive Coronary AngiographyPROCEDURE

Patient undergoes Invasive Coronary Angiography

Invasive Coronary Angiography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Patients providing written informed consent
  • Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

You may not qualify if:

  • Known CAD (myocardial infarction, PCI, CABG)
  • ACC/AHA Class I or III indication for ICA
  • 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 Glomerular Filtration Rate \<30 ml/min
  • Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
  • Heart rate ≥100 beats per minute
  • \) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index \>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Walter Reed Medical Center

Bethesda, Maryland, United States

Location

Quanta Diagnostico Nuclear, Curitiba-PR

Curitiba, Brazil

Location

FACTS

Hyderabad, India

Location

Centro Cardiologico Monzino

Monzino, Italy

Location

Institute of Cardiology Warsaw

Warsaw, Poland

Location

Kangwon National University Hospital

Seoul, South Korea, South Korea

Location

Ajou University Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Gangneung Asan Hospital

Seoul, South Korea

Location

Korea university, Guro hospital

Seoul, South Korea

Location

Pusan National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Yeongnam University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Chang HJ, Lin FY, Gebow D, An HY, Andreini D, Bathina R, Baggiano A, Beltrama V, Cerci R, Choi EY, Choi JH, Choi SY, Chung N, Cole J, Doh JH, Ha SJ, Her AY, Kepka C, Kim JY, Kim JW, Kim SW, Kim W, Pontone G, Valeti U, Villines TC, Lu Y, Kumar A, Cho I, Danad I, Han D, Heo R, Lee SE, Lee JH, Park HB, Sung JM, Leflang D, Zullo J, Shaw LJ, Min JK. Selective Referral Using CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected CAD: A Randomized, Controlled, Open-Label Trial. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 2):1303-1312. doi: 10.1016/j.jcmg.2018.09.018. Epub 2018 Dec 12.

    PMID: 30553687DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • James Min, MD

    Cornell Weill Medical College

    PRINCIPAL INVESTIGATOR

  • Dan Gebow, PhD

    MDDX LLC

    STUDY DIRECTOR

  • Hyuk-Jae Chang, MD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

March 13, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(1)PL(1)BR(1)IN(1)IT(1)KR(8)