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

Sponsor

Raffaele De Caterina (Other)

Overall Status

Completed

CT.gov ID

NCT01342848

Collaborator

San Giovanni Addolorata Hospital (Other)

Enrollment

Locations

Duration (Months)

25.3

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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 or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome

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.

Study Design

Study Type:

Observational

Actual Enrollment :

76 participants

Observational Model:

Cohort

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

The change in plaque volume as assessed by intravascular ultrasound (IVUS). [From baseline to 10 minutes after thromboaspiration (TA)]
The reduction of plaque volume after TA, assessed as (Baseline P+M)- (Post-TA P+M);

Secondary Outcome Measures

Histopathology assessment of aspirated material. [One week after PCI]
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 [Up to 72 hours after PCI]
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) [From baseline to 10 minutes after thromboaspiration (TA)]
Thrombus burden will be assessed with a semiquantitative scale (0-4) by OCT at baseline and after TA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Center of Predictive Molecular Medicine - University "G. d'Annunzio"	Chieti	Italy	66013
2	Institute of Cardiology, G. d'Annunzio University	Chieti	Italy	66100
3	San Giovanni Hospital and Centro per la Lotta Contro l'Infarto, Fondazione Onlus	Rome	Italy	00184