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

NCT ID: NCT02998853

Last Updated: 2016-12-21

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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STEMI - ST Elevation Myocardial Infarction Percutaneous Coronary Intervention Coronary Artery Disease

Keywords

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Non culprit STEMI PCI angio QFR FFR Staged procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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QFR measurement by dedicated workstation on xrays angio selected runs

The patient undergoes coronary angiography; if at least one stenosis from 40 to 90% in non culprit is present and FFR is indicated by guidelines the patient is enrolled to 3d Angio QFR evaluation; no adjunctive invasive procedures are needed for QFR measurements

Intervention Type OTHER

Other Intervention Names

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3d Angio QFR evaluation

Eligibility Criteria

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Inclusion Criteria

* STEMI/NSTEMI pts with at least 1 non culprit lesion \> 50%
* Age \> 18 years
* Able to provide signed informed consent
* 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


poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Sant'Anna e San Sebastiano

OTHER

Sponsor Role lead

Responsible Party

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dr. Domenico Di Girolamo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Domenico Di Girolamo

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Sant'Anna e San Sebastiano

Giuseppe MERCONE, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Sant'Anna e San Sebastiano

Locations

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Azienda Ospedaliera Sant-Anna e San Sebastiano

Caserta, Caserta, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Domenico Di Girolamo, MD

Role: CONTACT

Phone: +390823232550

Email: [email protected]

Giuseppe Mercone, MD

Role: CONTACT

Phone: +390823232550

Email: [email protected]

Facility Contacts

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Giuseppe Mercone, MD

Role: primary

Alfonso Alfieri, MD

Role: backup

References

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Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

Reference Type RESULT
PMID: 27712739 (View on PubMed)

Safi M, Eslami V, Namazi MH, Vakili H, Saadat H, Alipourparsa S, Adibi A, Movahed MR. Visual-Functional Mismatch Between Coronary Angiography, Fractional Flow Reserve, and Quantitative Coronary Angiography. Int J Angiol. 2016 Dec;25(4):229-234. doi: 10.1055/s-0035-1569992. Epub 2015 Dec 31.

Reference Type RESULT
PMID: 27867288 (View on PubMed)

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.

Reference Type RESULT
PMID: 27743953 (View on PubMed)

Indolfi C, Mongiardo A, Spaccarotella C, Torella D, Caiazzo G, Polimeni A, Sorrentino S, Micieli M, Sabatino J, Curcio A, De Rosa S. The instantaneous wave-free ratio (iFR) for evaluation of non-culprit lesions in patients with acute coronary syndrome and multivessel disease. Int J Cardiol. 2015 Jan 15;178:46-54. doi: 10.1016/j.ijcard.2014.03.210. Epub 2014 Oct 28.

Reference Type RESULT
PMID: 25464218 (View on PubMed)

Sulimov DS, Abdel-Wahab M, Richardt G. Fractional Flow Reserve in Acute Myocardial Infarction: A Guide for Non-Culprit Lesions? Cardiol Ther. 2015 Jun;4(1):39-46. doi: 10.1007/s40119-015-0040-4. Epub 2015 Jun 9.

Reference Type RESULT
PMID: 26055262 (View on PubMed)

Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

Reference Type RESULT
PMID: 26347918 (View on PubMed)

Morris PD, Ryan D, Morton AC, Lycett R, Lawford PV, Hose DR, Gunn JP. Virtual fractional flow reserve from coronary angiography: modeling the significance of coronary lesions: results from the VIRTU-1 (VIRTUal Fractional Flow Reserve From Coronary Angiography) study. JACC Cardiovasc Interv. 2013 Feb;6(2):149-57. doi: 10.1016/j.jcin.2012.08.024.

Reference Type RESULT
PMID: 23428006 (View on PubMed)

Morris PD, van de Vosse FN, Lawford PV, Hose DR, Gunn JP. "Virtual" (Computed) Fractional Flow Reserve: Current Challenges and Limitations. JACC Cardiovasc Interv. 2015 Jul;8(8):1009-1017. doi: 10.1016/j.jcin.2015.04.006. Epub 2015 Jun 24.

Reference Type RESULT
PMID: 26117471 (View on PubMed)

Papafaklis MI, Muramatsu T, Ishibashi Y, Lakkas LS, Nakatani S, Bourantas CV, Ligthart J, Onuma Y, Echavarria-Pinto M, Tsirka G, Kotsia A, Nikas DN, Mogabgab O, van Geuns RJ, Naka KK, Fotiadis DI, Brilakis ES, Garcia-Garcia HM, Escaned J, Zijlstra F, Michalis LK, Serruys PW. Fast virtual functional assessment of intermediate coronary lesions using routine angiographic data and blood flow simulation in humans: comparison with pressure wire - fractional flow reserve. EuroIntervention. 2014 Sep;10(5):574-83. doi: 10.4244/EIJY14M07_01.

Reference Type RESULT
PMID: 24988003 (View on PubMed)

Other Identifiers

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AOStAnnaSS

Identifier Type: -

Identifier Source: org_study_id