Status:
COMPLETED
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Lead Sponsor:
MDDX LLC
Collaborating Sponsors:
GE Healthcare
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- EXCLUSION CRITERIA
- 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
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
1631 Patients enrolled
Trial Details
Trial ID
NCT01810198
Start Date
December 1 2012
End Date
March 1 2016
Last Update
March 22 2017
Active Locations (13)
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1
Walter Reed Medical Center
Bethesda, Maryland, United States
2
Quanta Diagnostico Nuclear, Curitiba-PR
Curitiba, Brazil
3
FACTS
Hyderabad, India
4
Centro Cardiologico Monzino
Monzino, Italy