Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

NCT ID: NCT03055780

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-10-01

Brief Summary

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The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Detailed Description

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CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CT-FFR. CTA. FFR

59 patients with suspected CAD that have been scheduled for an interventional FFR study

CT-FFR. CTA. FFR

Intervention Type DEVICE

Study is to compare results of CT FFR against CTA and interventional FFR

Interventions

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CT-FFR. CTA. FFR

Study is to compare results of CT FFR against CTA and interventional FFR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* suspected coronary artery disease
* hemodynamically stable condition

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toshiba Medical Systems Corporation, Japan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SGD03-0667

Identifier Type: -

Identifier Source: org_study_id

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