Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR
Clinical Trial for SURECardio CT-FFR
1 other identifier
observational
59
0 countries
N/A
Brief Summary
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedFebruary 16, 2017
February 1, 2017
11 months
February 14, 2017
February 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis
one day
Study Arms (1)
CT-FFR. CTA. FFR
59 patients with suspected CAD that have been scheduled for an interventional FFR study
Interventions
Study is to compare results of CT FFR against CTA and interventional FFR
Eligibility Criteria
Suspected coronary artery disease
You may qualify if:
- suspected coronary artery disease
- hemodynamically stable condition
You may not qualify if:
- hemodynamic instability
- atrial fibrillation
- morbid obesity (BMI≥40 kg/m2)
- previous stent implantation
- recent myocardial infarction (within 30 days)
- age \<40 years
- renal insufficiency (eGFR \<60mL/min/1.73m2)
- bronchospastic lung disease requiring long term steroid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 16, 2017
Study Start
July 1, 2015
Primary Completion
May 30, 2016
Study Completion
October 1, 2016
Last Updated
February 16, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share