Multimodality Investigation of Intermediate Culprit Lesion With Negative FFR in NSTE-ACS

NCT03205514 | Completed DMC

• 1 other identifier: 160487
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Ten-fifteen percent of acute coronary syndromes without ST-segment elevation (NSTE-ACS) are caused by intermediate lesions without signs of unstable plaque. In this subset of patients, fractional flow reserve (FFR) has some drawbacks and may not be always able to predict outcome, especially when negative (above 0.80). In this particular nique of patients, advanced imaging techniques are suggested by International guidelines. However, it is actually unknown how these techniques may impact treatment strategies. With the present study, the investigators want to characterize the mechanism of disease in this particular subset of patients through multimodality imaging (intravascular ultrasound-near infrared spectroscopy (IVUS-NIRS), optical coherence tomography (OCT)) in order to understand the proper treatment.

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

• Plaque erosion incidence

  OCT-erosion: evidence of thrombotic material, irregular luminal surface without evidence of plaque fissure in multiple adjacent frames. IVUS/NIRS erosion: evidence of thrombotic material, irregular luminal surface without evidence of plaque fissure in multiple adjacent frames with lipid core burden index lower than the validated cutoff for unstable plaque (LCBI 4mm\<400).

  intra-procedure

Secondary Outcomes (8)

• Incidence of intermediate lesions with negative FFR in NSTE-ACS

  intra-procedure

• Vessel Lipid burden

  intra-procedure

• Plaque Lipid burden

  intra-procedure

• Apoptosis rate in HUVEC

  intra-procedure

• NO intracellular levels

  intra-procedure

Study Arms (1)

NSTE-ACS with intermediate stenosis and negative FFR

Patients hospitalized because of an acute coronary syndrome without ST segment elevation and with intermediate culprit lesion with negative fractional flow reserve evaluation (\>0.80).

Diagnostic Test: NSTE-ACS with intermediate stenosis and negative FFR

Interventions

NSTE-ACS with intermediate stenosis and negative FFR DIAGNOSTIC_TEST

Patients will undergo intracoronary imaging evaluation with IVUS-NIRS and OCT, endothelial function and inflammatory state evaluation.

NSTE-ACS with intermediate stenosis and negative FFR

Eligibility Criteria

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

Study Population

NSTE-ACS patients with intermediate culprit lesion (40-70%) and negative FFR (\>0.80).

You may qualify if:

• diagnosis of no-ST elevation-acute coronary syndrome
• clinical indication to coronary artery angiography
• angiographic documentation of intermediate lesion (40%-70%) with anterograde TIMI 3 flow eligible for FFR evaluation
• negative FFR evaluation (\>0.80)

You may not qualify if:

• cardiogenic shock
• any indication to stent treatment for lesion
• previous stent implantation on the target vessel
• left main disease
• massive thrombus presence in the culprit vessel
• life expectancy less than 12 months

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related Publications (6)

• Layland J, Oldroyd KG, Curzen N, Sood A, Balachandran K, Das R, Junejo S, Ahmed N, Lee MM, Shaukat A, O'Donnell A, Nam J, Briggs A, Henderson R, McConnachie A, Berry C; FAMOUS-NSTEMI investigators. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J. 2015 Jan 7;36(2):100-11. doi: 10.1093/eurheartj/ehu338. Epub 2014 Sep 1.

  PMID: 25179764 BACKGROUND

• Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

  PMID: 26320110 BACKGROUND

• Libby P, Pasterkamp G. Requiem for the 'vulnerable plaque'. Eur Heart J. 2015 Nov 14;36(43):2984-7. doi: 10.1093/eurheartj/ehv349. Epub 2015 Jul 22. No abstract available.

  PMID: 26206212 BACKGROUND

• Jia H, Abtahian F, Aguirre AD, Lee S, Chia S, Lowe H, Kato K, Yonetsu T, Vergallo R, Hu S, Tian J, Lee H, Park SJ, Jang YS, Raffel OC, Mizuno K, Uemura S, Itoh T, Kakuta T, Choi SY, Dauerman HL, Prasad A, Toma C, McNulty I, Zhang S, Yu B, Fuster V, Narula J, Virmani R, Jang IK. In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography. J Am Coll Cardiol. 2013 Nov 5;62(19):1748-58. doi: 10.1016/j.jacc.2013.05.071. Epub 2013 Jun 27.

  PMID: 23810884 BACKGROUND

• Campo G, Vieceli Dalla Sega F, Pavasini R, Aquila G, Gallo F, Fortini F, Tonet E, Cimaglia P, Del Franco A, Pestelli G, Pecoraro A, Contoli M, Balla C, Biscaglia S, Rizzo P, Ferrari R. Biological effects of ticagrelor over clopidogrel in patients with stable coronary artery disease and chronic obstructive pulmonary disease. Thromb Haemost. 2017 Mar 23;117(6):1208-1216. doi: 10.1160/TH16-12-0973. Epub 2017 Mar 23.

  PMID: 28331925 BACKGROUND

• Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

  PMID: 15189396 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Simone Biscaglia, MD

  Ferrara University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: June 28, 2017
• Primary Completion: June 5, 2018
• Study Completion: April 28, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)