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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02998853
• Other study ID #: AOStAnnaSS
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: December 16, 2016
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Azienda Ospedaliera Sant'Anna e San Sebastiano
• Contact: Domenico Di Girolamo, MD
• Phone: +390823232550
• Email: mimmo.digirolamo[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Sant-Anna e San Sebastiano	Caserta

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Sant'Anna e San Sebastiano

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3—PRIMULTI Investigators.. Compl — View Citation

Gaur S, Taylor CA, Jensen JM, Bøtker HE, Christiansen EH, Kaltoft AK, Holm NR, Leipsic J, Zarins CK, Achenbach S, Khem S, Wilk A, Bezerra HG, Lassen JF, Nørgaard BL. FFR Derived From Coronary CT Angiography in Nonculprit Lesions of Patients With Recent ST — View Citation

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 — View Citation

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 Angiogr — View Citation

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):1009-17. doi: 10.1016/j.jcin.2015.04.006. Review. — View Citation

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, Mich — View Citation

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. — View Citation

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. — View Citation

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 JH, Holm NR, Wijns W; FAVOR Pilot Trial Study Group.. Diagnostic Accuracy of Fast Computational Approaches to Der — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio	1 - 15 days	No
Secondary	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	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	No
Secondary	Diagnostic accuracy of TIMI flow based for computing QFR in staged study in comparison with Hyperemic FFR in the same lesion	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	No