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HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography (HFNXT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757678
First Posted: December 31, 2012
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
HeartFlow, Inc.
Results First Submitted: July 28, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Interventions: Procedure: ICA (Invasive Coronary Angiography)
Procedure: FFR (Fractional Flow Reserve)
Procedure: cCTA (coronary computed tomography angiography)
Other: FFRct Analysis (Fractional Flow Reserve Computed Tomography)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard of Care: FFR and ICA

Single arm

Measured FFR: Fractional Flow Reserve


Participant Flow:   Overall Study
    Standard of Care: FFR and ICA
STARTED   276 
COMPLETED   276 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard of Care: FFR and ICA

Single arm

Measured FFR (Fractional Flow Reserve) and ICA (Invasive Coronary Angiography)


Baseline Measures
   Standard of Care: FFR and ICA 
Overall Participants Analyzed 
[Units: Participants]
 276 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      101  36.6% 
Male      175  63.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      91  33.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      179  64.9% 
More than one race      0   0.0% 
Unknown or Not Reported      6   2.2% 
Diabetes 
[Units: Participants]
 
With Diabetes   62 
Without Diabetes   214 
Hypertension 
[Units: Participants]
 
With Hypertension   188 
Without Hypertension   88 
Hyperlipidemia 
[Units: Participants]
 
With Hyperlipidemia   214 
Without Hyperlipidemia   60 
Unknown Hiperlipidemia Status   2 
Current smoker 
[Units: Participants]
 
Current Smoker   50 
Former Smoker   106 
Never Smoked   118 
Unknown   2 
Previous myocardial infarction 
[Units: Participants]
 
Previous Myocardial Infarction   5 
No Previous Myocardial Infarction   271 
Body Mass Index, kg/m^2 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26  (4) 
Creatinine, mg/dl 
[Units: Mg/dl]
Mean (Standard Deviation)
 0.9  (.2) 
Left ventricular ejection fraction, % 
[Units: Percent]
Mean (Standard Deviation)
 62  (7) 


  Outcome Measures
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1.  Primary:   AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis   [ Time Frame: 1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan. ]

2.  Secondary:   AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis   [ Time Frame: 1 day ]

3.  Secondary:   Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA   [ Time Frame: 1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan. ]

4.  Secondary:   Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA   [ Time Frame: 1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan. ]

5.  Post-Hoc:   Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA   [ Time Frame: 1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
13% of patients were judged to have nonevaluable cCTA images on the basis of a pre-defined image quality score. This number may be reduced with improvement of CT acquisition techniques as well a refinement of the FFRct technology.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: VP Clinical, Quality & Regulatory Affairs
Organization: HeartFlow
phone: 650-241-1221
e-mail: clinicalresearch@heartflow.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT01757678     History of Changes
Other Study ID Numbers: CP-902-001
First Submitted: December 18, 2012
First Posted: December 31, 2012
Results First Submitted: July 28, 2014
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017