N/A
N=276
HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01757678 ↗Enrolled (actual)
276
Serious AEs
1.8%
Results posted
Nov 2017
Primary outcome: Primary: AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis — .90; .81 probablility
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ICA (Invasive Coronary Angiography) (Procedure); FFR (Fractional Flow Reserve) (Procedure); cCTA (coronary computed tomography angiography) (Procedure); FFRct Analysis (Fractional Flow Reserve Computed Tomography) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HeartFlow, Inc.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis |
.90; .81 | — |
| SECONDARY AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis |
.93; .79 | — |
| SECONDARY Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA |
77; 81; 53; 64; 86; 94 | — |
| SECONDARY Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA |
82; 86; 65; 55; 84; 83 | — |
Summary
To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a hemodynamically significant coronary lesion, using direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Subject providing written informed consent
- Scheduled to undergo a clinically indicated Invasive Coronary Angiogram (ICA)
- Has had ≥64 multidetector row cCTA within 60 days prior to ICA or agrees to undergo cCTA with ≥64 multidetector row cCTA within 60 days prior to ICA
Exclusion Criteria
- Percutaneous coronary intervention (PCI) has been performed any time prior to ICA.
- Prior coronary artery bypass graft (CABG) surgery
- Contraindication to beta blocker agents, nitrates, or adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension; severe asthma, severe COPD or bronchodilator-dependent COPD
- Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
- Recent prior myocardial infarction within 30 days prior to cCTA or between cCTA and ICA
- Known complex congenital heart disease
- Prior pacemaker or internal defibrillator lead implantation
- Prosthetic heart valve
- Tachycardia or significant arrhythmia
- Impaired chronic renal function (serum creatinine >1.5 mg/dl)
- Subjects with known anaphylactic allergy to iodinated contrast
- Pregnancy or unknown pregnancy status in subject of childbearing potential
- Body mass index >35 at time of cCTA
- Subject requires an emergent procedure
- Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
- Any active, serious, life-threatening disease with a life expectancy of less than 2 months
- Inability to comply with study procedures
Data sourced from ClinicalTrials.gov (NCT01757678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.