Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05727982 |
Other study ID # |
2747 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 13, 2019 |
Est. completion date |
September 13, 2024 |
Study information
Verified date |
February 2023 |
Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact |
Giovanna GL Liuzzo |
Phone |
06/30154187 |
Email |
giovanna.liuzzo[@]policlinicogemelli.it |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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 and/or myocardial
perfusion imaging). Patients showing Q waves on 12-lead electrocardiogram and/or abnormal
echocardiogram (ie, left ventricular ejection fraction <40% and/or 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 1:3 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.