Assessment of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.
Assessment of the Functional Significance of Coronary Stenoses Using Coronary CT-angiography and Non-invasive Fractional Flow Reserve Measurement.
1 other identifier
observational
64
1 country
1
Brief Summary
The purpose of this study is to determine whether a novel non-invasive method to estimate coronary blood flow (FFRct) is applicable to evaluate the functional significance of coronary stenoses in non-culprit vessels in a population of patients with recent STEMI (ST-elevation myocardial infarction) and multivessel disease. The diagnostic performance and reproducibility of FFRct as well as the qualitative and quantitative correlation between FFRct and the regional coronary blood flow will be examined.
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 Mar 2012
1 active site
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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJune 2, 2014
August 1, 2013
2 years
November 27, 2012
May 30, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
FFRct measurement
Acute measurement
FFR measurement
Acute assessment
Secondary Outcomes (1)
Absolute regional myocardial perfusion
Acute assessment
Eligibility Criteria
Patients with STEMI admitted at Aarhus Universtity Hospital and treated with primary PCI, and where the operater finds one or more residual stenoses in non-culprit vessels that needs to be assessed at a later time with ICA and FFR.
You may qualify if:
- Recent STEMI and indication for new ICA to assess non-culprit lesions
You may not qualify if:
- contraindications to adenosine
- allergy to contrast agent
- P-creatinine \> 125 micromol/L
- atrial fibrillation
- age \< 18 years
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus N, 8200, Denmark
Related Publications (1)
Gaur S, Taylor CA, Jensen JM, Botker HE, Christiansen EH, Kaltoft AK, Holm NR, Leipsic J, Zarins CK, Achenbach S, Khem S, Wilk A, Bezerra HG, Lassen JF, Norgaard BL. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent STEMI. JACC Cardiovasc Imaging. 2017 Apr;10(4):424-433. doi: 10.1016/j.jcmg.2016.05.019. Epub 2016 Oct 12.
PMID: 27743953DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Gaur, MD
Aarhus University Hospital
- STUDY CHAIR
Bjarne L Nørgaard, MD, Ph.D.
Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 30, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 2, 2014
Record last verified: 2013-08