NCT04375319: EXPECT

OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS)

Status unknown NA Last updated 5 May 2020

What this trial tests

NA trial testing OCT in Unstable Anginas in 60 participants. Status unknown.

Timeline

28 October 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Xuzhou Third People's Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	28 October 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	2 locations across China

Drugs / interventions tested

• OCT

Conditions studied

• Unstable Anginas — all drugs for Unstable Anginas →
• Non ST Segment Elevation Myocardial Infarction — all drugs for Non ST Segment Elevation Myocardial Infarction →

Sponsor

Xuzhou Third People's Hospital

Who can join

Adults 18 to 80, any sex, with Unstable Anginas or Non ST Segment Elevation Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective study of a new generation of drug-eluting stent in the treatment of non ST elevation acute coronary syndrome (NSTE-ACS). The purpose of this study was to evaluate the extent of early vascular repair in NSTE-ACS patients after receiving the new generation of drug-eluting stents, and the value of OCT guided optimal implantation in further improving the target vascular endothelial repair, so as to provide the basis for early discontinuation of dual antiplatelet drugs (dapt) in NSTE-ACS patients and later large-scale randomized clinical research.This study is a prospective, multicenter, randomized controlled clinical study. Sixty patients with non ST elevation acute coronary syndrome (NSTE-ACS), including unstable angina and acute non ST elevation myocardial infarction, were enrolled in this study. After obtaining the written consent of the patients, the computer-generated random sequence table was randomly divided into three-month follow-up group (O3 group, n = 20), three-month follow-up group (A3 group, n = 20) and six-month follow-up group (A6 group, n = 20). Among them, the OCT guidance group needs to optimize the operation according to the examination results before and after the operation, while the contrast guidance group only conducts OCT examination collection after the operation. During the study period, all patients were given dual antiplatelet therapy (aspirin 100mg / D, clopidogrel 75mg QD or tegrilol 90mg bid). Sixty patients were followed up at 30 days, 3 months, 6 months and 1 year after stent implantation, and OCT was performed at 3 or 6 months after stent implantation, with the coverage rate of neointima as the main observation index. In this experiment, the independent OCT imaging laboratory, data management and Statistics Center, clinical endpoint determination Committee and clinical supervision organization collected, sorted, statistically analyzed and determined all relevant clinical and OCT imaging data. All the selected patients were followed up continuously within one year (telephone or outpatient follow-up) to observe the occurrence of adverse events.Primary end point: stent endometrial coverage measured by OCT (%)。

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early vascular healing after neXt-generation drug-eluting stent implantation in Patients with non-ST Elevation acute Coronary syndrome based on optical coherence Tomography guidance and evaluation (EXPECT): study protocol for a randomized controlled trial.
   Zhu YX, Liang L, Parasa R, Li Z, et al · · 2023 · PMID 36910518 · DOI 10.3389/fcvm.2023.1003546