Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure

December 16, 2016 updated by: dr. Domenico Di Girolamo, Azienda Ospedaliera Sant'Anna e San Sebastiano

Reliability of 3D Angio QFR Evaluation of Non Culprit Stenoses in STEMI Patients During First Acute Interventional Procedure: Comparison With Staged Procedure FFR

Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI patients during first acute procedure

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non culprit lesion in staged procedure. Aim of the study is to find a valid correlation between cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for STEMI patients, selecting those,if any, to be treated immediately or in a staged procedure.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Caserta, Italy, 81100
        • Recruiting
        • Azienda Ospedaliera Sant-Anna e San Sebastiano
        • Contact:
        • Contact:
          • Alfonso Alfieri, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive STEMI patients with at least one non culprit artery with stenosis >50%.

Description

Inclusion Criteria:

  • STEMI/NSTEMI pts with at least 1 non culprit lesion > 50%
  • Age > 18 years
  • Able to provide signed informed consent
  • Angiographic inclusion criteria:
  • Indication for FFR in at least one stenosis:
  • Diameter stenosis of 50%-90% by visual estimate
  • Reference vessel size > 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

  • Severe asthma or severe chronic obstructive pulmonary disease
  • Severe heart failure (NYHA≥III)
  • S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
  • Allergy to contrast media or adenosine
  • Atrial fibrillation

Angiographic exclusion criteria:

poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of TIMI flow based with contrast hyperemia QFR in acute study comparison to FFR in staged procedure reported as positive and negative likelihood ratio in the same lesion
Time Frame: 1 - 15 days
Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
1 - 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion
Time Frame: 0-15 days
Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion
0-15 days
Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion
Time Frame: 0-1 hour
Diagnostic accuracy of TIMI flow based for computing QFR in acute study in comparison with TIMI flow based for computing QFR in staged in the same lesion
0-1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Sant'Anna e San Sebastiano

Investigators

  • Principal Investigator: Domenico Di Girolamo, Azienda Ospedaliera Sant'Anna e San Sebastiano
  • Principal Investigator: Giuseppe MERCONE, MD, Azienda Ospedaliera Sant'Anna e San Sebastiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOStAnnaSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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