Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727982
Status:
RECRUITING
Last Update Posted:
2023-02-14
First Post:
2023-02-02
Brief Title:
Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine PRECISION Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISION
Brief Summary:
To further improve the outcome of ACS it is strongly needed to identify new therapeutic targets This is possible only by improving our knowledge of the multiple molecular mechanisms leading to coronary instability through several pathways The goal of this project is to define the molecular mechanisms responsible for the four different presentations of ACS to identify biomarkers for their noninvasive identification and potential new therapeutic targets thus promoting precision medicine
Detailed Description:
This is a multicenter prospective observational study involving 5 Research Units RU the enrollment-phase will take 18 months month 6 to 24 This is an explorative project that will prospectively enroll 1 Consecutive patients with an admission diagnosis of ACS with Non ST elevation myocardial infarction NSTEMI confirmed at coronary angiography undergoing OCT evaluation of the culprit coronary plaque before stent implantation for clinical reasons and with a clearly identifiable feature of the culprit plaques according to current European guidelines ECG changes may include transient ST- segment elevation persistent or transient ST-segment depression T-wave inversion flat T waves or pseudo- normalization of T waves or the ECG may be normal Taking into account our previous studies the investigators estimated that between 30-35 of NSTEMI patients will undergo OCT evaluation 2 Consecutive patients with symptoms of Stable Angina SA lasting 12 months angiographically confirmed coronary artery disease without any episode suggestive of previous acute event and no overt ischemic episodes during the last 48 hours according to current European guidelines Myocardial ischemia was documented by afunctional test ie exercise treadmill testing andor myocardial perfusion imaging Patients showing Q waves on 12-lead electrocardiogram andor abnormal echocardiogram ie left ventricular ejection fraction 40 andor wall motion abnormalities were excluded NSTEMI within 12 hours of symptom onset and SA patients will be enrolled at the time of their admission to the Coronary Care Unit and to the SubIntensive Cardiac Care Unit of wich Prof Giovanna Liuzzo project PI is the supervising physician 3 In the same period consecutive Mitral Valve Disease patients MVD with angiographically normal coronary arteries undergoing surgery for mitral valve regurgitation age and sex matched 13 with NSTEMI patients will be enrolled as control group MVD patients will be enrolled at Cardiosurgery Operative Unit lead by Professor Massimo Massetti
Our RU1 will enroll
1 150 consecutive patients with an admission diagnosis of NSTEMI
2 50 consecutive patients with a diagnosis of SA
3 50 consecutive MVD
Our RU1 will enroll
1 150 consecutive patients with an admission diagnosis of NSTEMI
2 50 consecutive patients with a diagnosis of SA
3 50 consecutive MVD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None