Online Tai Chi Plus Fitbit After ACS
NCT05699642
Acute Coronary Syndrome, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT01342848
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.
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Notify Me18 year–75 year
All sexes
Observational
Center of Predictive Molecular Medicine - University "G. d'Annunzio", Chieti, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From baseline to 10 minutes after thromboaspiration (TA)
The reduction of plaque volume after TA, assessed as (Baseline P+M)- (Post-TA P+M);
Time frame: 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.
Time frame: 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
Time frame: 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
Raffaele De Caterina
Other
REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration
Acronym: REMNANT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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