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

NCT02998853 | Unknown

• 1 other identifier: AOStAnnaSS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Non culprit; STEMI PCI; angio QFR; FFR; Staged procedure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

  0-1 hour

Interventions

QFR measurement by dedicated workstation on xrays angio selected runs OTHER

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

Also known as: 3d Angio QFR evaluation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Sant'Anna e San Sebastiano: lead

Study Sites (1)

Azienda Ospedaliera Sant-Anna e San Sebastiano

Caserta, Caserta, 81100, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 27712739 RESULT

• 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.

  PMID: 27867288 RESULT

• 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: 27743953 RESULT

• 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.

  PMID: 25464218 RESULT

• 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.

  PMID: 26055262 RESULT

• 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.

  PMID: 26347918 RESULT

• 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.

  PMID: 23428006 RESULT

• 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.

  PMID: 26117471 RESULT

• 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.

  PMID: 24988003 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Domenico Di Girolamo

  Azienda Ospedaliera Sant'Anna e San Sebastiano

  PRINCIPAL INVESTIGATOR

• Giuseppe MERCONE, MD

  Azienda Ospedaliera Sant'Anna e San Sebastiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico Di Girolamo, MD

CONTACT

+390823232550; mimmo.digirolamo@gmail.com

Giuseppe Mercone, MD

CONTACT

+390823232550; mimmo.digirolamo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

IT (1)