Effectiveness of Thrombus Aspiration in Plaque Reduction for Patients With Acute Coronary Syndromes (REMNANT)
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.
Acute Coronary Syndrome
|Study Design:||Observational Model: Cohort|
|Official Title:||REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration|
- 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);
- 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
|Study Start Date:||March 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342848
|Center of Predictive Molecular Medicine - University "G. d'Annunzio"|
|Chieti, Italy, 66013|
|Institute of Cardiology, G. d'Annunzio University|
|Chieti, Italy, 66100|
|San Giovanni Hospital and Centro per la Lotta Contro l'Infarto, Fondazione Onlus|
|Rome, Italy, 00184|