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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by G. d'Annunzio University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
San Giovanni Addolorata Hospital
Information provided by (Responsible Party):
Prof. Raffaele De Caterina, G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT01342848
First received: April 12, 2011
Last updated: August 22, 2011
Last verified: April 2011
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • The change in plaque volume as assessed by intravascular ultrasound (IVUS). [ Time Frame: From baseline to 10 minutes after thromboaspiration (TA) ] [ Designated as safety issue: No ]
    The reduction of plaque volume after TA, assessed as (Baseline P+M)- (Post-TA P+M);


Secondary Outcome Measures:
  • Histopathology assessment of aspirated material. [ Time Frame: One week after PCI ] [ Designated as safety issue: No ]
    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.

  • Myocardial infarct size by markers of myocardial injury/necrosis [ Time Frame: Up to 72 hours after PCI ] [ Designated as safety issue: Yes ]
    Myocardial infarct size will be determined as the area under the curve of serial CK-MB and cardiac Troponin I assessment

  • The change in thrombus burden as assessed by Optical Coherence Tomography (OCT) [ Time Frame: From baseline to 10 minutes after thromboaspiration (TA) ] [ Designated as safety issue: No ]
    Thrombus burden will be assessed with a semiquantitative scale (0-4) by OCT at baseline and after TA


Biospecimen Retention:   Samples Without DNA

Histopathology assessment of aspirated material during manual TA. 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


Estimated Enrollment: 45
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342848

Contacts
Contact: Raffaele De Caterina, MD/PhD +39 0871 41512 rdecater@unich.it

Locations
Italy
Institute of Cardiology, G. d'Annunzio University Recruiting
Chieti, Italy, 66100
Contact: Raffaele De Caterina, MD/PhD    +39 0871 41512    rdecater@unich.it   
Sub-Investigator: Marco Zimarino, MD, PhD         
Sub-Investigator: Luca Barnabei, MD         
Sub-Investigator: Benedetta Ruggieri, MD         
Sub-Investigator: Francesca Angeramo, MD         
Sub-Investigator: Mariangela D'Andreamatteo, MD         
Center of Predictive Molecular Medicine - University "G. d'Annunzio" Recruiting
Chieti, Italy, 66013
Contact: Antonio Marchetti, Professor    +39 348 7786577    amarchetti@unich.it   
Principal Investigator: Antonio Marchetti, MD, PhD         
Sub-Investigator: Sara Malatesta, MD         
San Giovanni Hospital and Centro per la Lotta Contro l'Infarto, Fondazione Onlus Recruiting
Rome, Italy, 00184
Contact: Francesco Prati, MD       fprati@hsangiovanni.roma.it   
Principal Investigator: Francesco Prati, MD         
Sub-Investigator: Fabrizio Imola, MD         
Sponsors and Collaborators
Prof. Raffaele De Caterina
San Giovanni Addolorata Hospital
  More Information

Publications:
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. Review.

Responsible Party: Prof. Raffaele De Caterina, Director - Institute of Cardiology, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01342848     History of Changes
Other Study ID Numbers: 2010-021835-15
Study First Received: April 12, 2011
Last Updated: August 22, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:
NSTE-ACS
PCI
Thrombus Aspiration
IVUS
Periprocedural Myocardial Infarction

Additional relevant MeSH terms:
Thrombosis
Acute Coronary Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014