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Acute Coronary SyndromeREMNANTNCT01342848

Effectiveness of Thrombus Aspiration in Plaque Reduction for Patients With Acute Coronary Syndromes

An observational study of Acute Coronary Syndrome, run by Raffaele De Caterina at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although successful, percutaneous coronary interventions (PCI) with stent implantation may be hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an occluded coronary artery has been documented… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Coronary Syndrome
How many people
76 participants
Where
3 sitesItaly
Study dates
Mar 2011to Oct 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 45 patients with at least one "culprit" lesion, identified as a high-grade (>90%) lesion in the territory of jeopardized myocardium, at coronary angiography performed for a recent (<15 days, but after 24 hours) STEMI or a non-ST elevation (NSTE)-ACS within 72 hours of symptoms.

Who may be able to join

  • Age between 18-75 years old.
  • Recent(<15 days, >24 hrs)STEMI or NSTE-ACS within 72 hrs of symptoms.
  • Presence at least one "culprit" high-grade (>90%)lesion.

Who cannot join

  • STEMI within 24 hours.
  • Cardiogenic shock, decompensated heart failure, LVEF<30%.
  • Serum creatinine ≥ 2.5 mg/dl.
  • Contraindication to aspirin, heparin, thienopyridines.
  • Total occlusion of target vessel.
  • Diseased vein graft or a restenosis.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • Center of Predictive Molecular Medicine - University "G. d'Annunzio"

    Chieti, 66013

  • Institute of Cardiology, G. d'Annunzio University

    Chieti, 66100

  • San Giovanni Hospital and Centro per la Lotta Contro l'Infarto, Fondazione Onlus

    Rome, 00184

Other trials in Italy

About this study

Official title: REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration

Although successful, percutaneous coronary interventions (PCI) with stent implantation may be hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an occluded coronary artery has been documented to produce an improved myocardial perfusion rate and significant survival advantage. To date, beyond feasibility and safety studies no clinical benefit has been yet documented with the use of TA before stent deployment in the setting of acute coronary syndromes (ACS) outside acute STEMI. The investigators hypothesize that TA before stent deployment reduces the thrombus/plaque burden - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes (ACS) outside acute STEMI.

Read the detailed description

Periprocedural myocardial infarction (MI) has an independent adverse prognostic relevance. Several trials have documented a reduction in the occurrence of periprocedural MI through various pharmacological strategies, with enhanced inhibition of platelet aggregation or high dose statins. However, real-world registries still document an incidence of periprocedural MI in 30-40% of patients. Currently available intravascular imaging techniques, Intravascular Ultrasound (IVUS) and more recently available Optical Coherence Tomography (OCT) allow a precise evaluation of the coronary plaque and can be extremely useful for monitoring plaque modifications obtained with thrombus aspiration (TA). Plaque burden will be assessed as plaque + media (P+M), commonly measured with IVUS by subtracting lumen (L) to external elastic membrane (EEM) cross sectional area (P+M= EEM-L).

Expecting a mean plaque volume of 160±50 mm3 in a population of patients with ACS undergoing PCI, a sample size of at least 45 patients (52 lesions) with a recent (<15 days, but after 24 hours) STEMI or a non-ST elevation (NSTE)-ACS within 72 hours of symptoms would provide a 90% power to detect a 20% reduction in the plaque volume after TA with an alpha (probability value) of 0.05.

Keywords
NSTE-ACS, PCI, Thrombus Aspiration, IVUS, Periprocedural Myocardial Infarction
Medical subject headings
Acute Coronary Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in plaque volume as assessed by intravascular ultrasound (IVUS).

    The reduction of plaque volume after TA, assessed as (Baseline P+M)- (Post-TA P+M);

    Measured: From baseline to 10 minutes after thromboaspiration (TA)

Secondary outcomes (3)

  1. Histopathology assessment of aspirated material.

    Quantitative analysis: size and weight. Qualitative evaluation: a) thrombus containing only platelets, b) a thrombus with an erythrocyte component c) any fragment of vessel wall, cholesterol crystals, inflammatory cells or collagen tissue.

    Measured: One week after PCI

  2. Myocardial infarct size by markers of myocardial injury/necrosis

    Myocardial infarct size will be determined as the area under the curve of serial CK-MB and cardiac Troponin I assessment

    Measured: Up to 72 hours after PCI

  3. The change in thrombus burden as assessed by Optical Coherence Tomography (OCT)

    Thrombus burden will be assessed with a semiquantitative scale (0-4) by OCT at baseline and after TA

    Measured: From baseline to 10 minutes after thromboaspiration (TA)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342848
Sponsor's protocol ID
2010-021835-15
Acronym
REMNANT
Status last verified
Jun 2015
First submitted
12 Apr 2011
Last updated
8 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.

    PubMed 15769784

  • Iakovou I, Mintz GS, Dangas G, Abizaid A, Mehran R, Kobayashi Y, Lansky AJ, Aymong ED, Nikolsky E, Stone GW, Moses JW, Leon MB. Increased CK-MB release is a "trade-off" for optimal stent implantation: an intravascular ultrasound study. J Am Coll Cardiol. 2003 Dec 3;42(11):1900-5. doi: 10.1016/j.jacc.2003.06.012.

    PubMed 14662249

  • Prati F, Pawlowski T, Gil R, Labellarte A, Gziut A, Caradonna E, Manzoli A, Pappalardo A, Burzotta F, Boccanelli A. Stenting of culprit lesions in unstable angina leads to a marked reduction in plaque burden: a major role of plaque embolization? A serial intravascular ultrasound study. Circulation. 2003 May 13;107(18):2320-5. doi: 10.1161/01.CIR.0000066695.24697.07. Epub 2003 Apr 21.

    PubMed 12707236

  • Nienhuis MB, Ottervanger JP, Bilo HJ, Dikkeschei BD, Zijlstra F. Prognostic value of troponin after elective percutaneous coronary intervention: A meta-analysis. Catheter Cardiovasc Interv. 2008 Feb 15;71(3):318-24. doi: 10.1002/ccd.21345.

    PubMed 18288753

  • Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur Heart J. 2007 Oct;28(20):2525-38. doi: 10.1093/eurheartj/ehm355. No abstract available.

    PubMed 17951287

  • Kastrati A, Mehilli J, Neumann FJ, Dotzer F, ten Berg J, Bollwein H, Graf I, Ibrahim M, Pache J, Seyfarth M, Schuhlen H, Dirschinger J, Berger PB, Schomig A; Intracoronary Stenting and Antithrombotic: Regimen Rapid Early Action for Coronary Treatment 2 (ISAR-REACT 2) Trial Investigators. Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial. JAMA. 2006 Apr 5;295(13):1531-8. doi: 10.1001/jama.295.13.joc60034. Epub 2006 Mar 13.

    PubMed 16533938

  • Patti G, Colonna G, Pasceri V, Pepe LL, Montinaro A, Di Sciascio G. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005 Apr 26;111(16):2099-106. doi: 10.1161/01.CIR.0000161383.06692.D4. Epub 2005 Mar 6.

    PubMed 15750189

  • Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. doi: 10.1161/01.CIR.0000137828.06205.87. Epub 2004 Jul 26.

    PubMed 15277322

  • Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416.

    PubMed 18256391

  • Vlaar PJ, Diercks GF, Svilaas T, Vogelzang M, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. The feasibility and safety of routine thrombus aspiration in patients with non-ST-elevation myocardial infarction. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):937-42. doi: 10.1002/ccd.21717.

    PubMed 19021272

  • Zimarino M, Prati F, Stabile E, Pizzicannella J, Fouad T, Filippini A, Rabozzi R, Trubiani O, Pizzicannella G, De Caterina R. Optical coherence tomography accurately identifies intermediate atherosclerotic lesions--an in vivo evaluation in the rabbit carotid artery. Atherosclerosis. 2007 Jul;193(1):94-101. doi: 10.1016/j.atherosclerosis.2006.08.047. Epub 2006 Sep 27.

    PubMed 17007862

  • Prati F, Regar E, Mintz GS, Arbustini E, Di Mario C, Jang IK, Akasaka T, Costa M, Guagliumi G, Grube E, Ozaki Y, Pinto F, Serruys PW; Expert's OCT Review Document. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010 Feb;31(4):401-15. doi: 10.1093/eurheartj/ehp433. Epub 2009 Nov 4.

    PubMed 19892716

  • Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Juhani Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I. Circulation. 2003 Oct 7;108(14):1664-72. doi: 10.1161/01.CIR.0000087480.94275.97.

    PubMed 14530185

  • Zimarino M, Calafiore AM, De Caterina R. Complete myocardial revascularization: between myth and reality. Eur Heart J. 2005 Sep;26(18):1824-30. doi: 10.1093/eurheartj/ehi249. Epub 2005 Apr 11.

    PubMed 15824076

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Raffaele De Caterina at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in plaque volume as assessed by intravascular ultrasound (IVUS). (time frame: From baseline to 10 minutes after thromboaspiration (TA)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342848, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.

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