The percutaneous assessment of regional and acute coronary hot unstable plaques by thermographic evaluation (PARACHUTE) study: a prospective reproducibility and prognostic clinical study using thermography to predict future ischemic cardiac events.
Intravascular thermography is currently being considered as a valuable tool in assessing macrophage-rich plaques. Since it is unknown what the prognostic value is of non-obstructive atherosclerotic plaques showing temperature heterogeneity, we designed the PARACHUTE study, a prospective, reproducibility, and prognostic clinical study using thermography in patients presenting with an unstable coronary syndrome. The primary endpoint of the study is the predictive value of temperature heterogeneity towards the occurrence of ischemic coronary events and hospitalization for ischemia and/or angina. The secondary endpoints are the predictive value of high-risk plaques associated with the development of future cardiac events, assessment of safety of the procedure, assessment of temperature reproducibility and heterogeneity in coronary arteries, as defined by the total thermal burden towards the occurrence of any cardiac event. Based on an event rate of death and myocardial infarction at 1 year of 10%, a sample size of 260 patients with presumed coronary artery disease, and positive troponin level who are scheduled to undergo an intervention will be included. All three main epicardiac vessels will undergo angiography and thermography at baseline after revascularization of the flow-limiting vessel. At 12 months, angiography of all vessels and thermography of the vessel with the highest thermographic burden will be performed. Independent core laboratories will assess outcomes and a clinical endpoint committee will assess clinical events.
Verheye
Stefan
S
Department of Interventional Cardiology, Middelheim Hospital, Antwerp, Belgium. stefan.verheye@pandora.be
Van Langenhove
Glenn
G
van Es
Gerrit-Anne
GA
Serruys
Patrick
P
D000208:Acute Disease; D000789:Angina, Unstable / Q000175:diagnosis; D017023:Coronary Angiography; D003327:Coronary Disease / Q000175:diagnosis*; D005500:Follow-Up Studies; D005544:Forecasting; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis; D017202:Myocardial Ischemia / Q000175:diagnosis; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D012372:ROC Curve; D015203:Reproducibility of Results; D013817:Thermography