Clinical trial NCT01810198: Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Official title: Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Cardiac CT
Catheterization
Lead sponsor: MDDX LLC
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2013-03-13
Enrollment: 1631
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.

Eligibility criteria: INCLUSION CRITERIA

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

EXCLUSION CRITERIA

1. Known CAD (myocardial infarction, PCI, CABG)
2. ACC/AHA Class I or III indication for ICA
3. Non-cardiac illness with life expectancy \<2 years
4. Inability to provide written informed consent
5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
6. Pregnant women
7. Allergy to iodinated contrast agent
8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate \<30 ml/min
9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
10. Heart rate ≥100 beats per minute

12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index \>35

Primary outcomes:
measure: MACE Endpoints
timeFrame: 1 year
Secondary outcomes:
measure: Additional MACE Endpoints
timeFrame: 1 year
Other outcomes:
measure: Economic
timeFrame: 1 year
measure: Secondary Safety Endpoint
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
Locations:
city: Bethesda
country: United States
facility: Walter Reed Medical Center
state: Maryland
city: Curitiba
country: Brazil
facility: Quanta Diagnostico Nuclear, Curitiba-PR
city: Hyderabad
country: India
facility: FACTS
city: Monzino
country: Italy
facility: Centro Cardiologico Monzino
city: Seoul
country: Korea, Republic of
facility: Kangwon National University Hospital
state: South Korea
city: Seoul
country: Korea, Republic of
facility: Ajou University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea university, Guro hospital
city: Seoul
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Yeongnam University Hospital
city: Warsaw
country: Poland
facility: Institute of Cardiology Warsaw
Study officials:
affiliation: Cornell Weill Medical College
name: James Min, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MDDX LLC
name: Dan Gebow, PhD
role: STUDY_DIRECTOR
affiliation: Severance Hospital
name: Hyuk-Jae Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.