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

NCT04375319 | Unknown

• 1 other identifier: IEC-C-008-A07-V1.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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 (%)。

Conditions

Unstable Anginas; Non ST Segment Elevation Myocardial Infarction

Keywords

Optical Coherence Tomography; Drug Eluting Stents; EXCROSSAL

Outcome Measures

Primary Outcomes (1)

• Stent endometrial coverage measured by OCT

  Patients were randomly assigned to the 3-month or 6-month follow-up group。According to the randomized group, Oct reexamination was carried out at 3 or 6 months after the operation to evaluate the stent endometrial coverage rate。

  3 to 6 months after operation

Secondary Outcomes (11)

• Poor adherence rate of stent wire during follow-up

  3 to 6 months after operation

• minimum and average lumen area, the minimum stent area and the average stent area

  3 to 6 months after operation

• Minimum stent diameter and average stentdiameter,minimum lumen diameter and average lumen diameter

  3 to 6 months after operation

• Covering thickness of scaffold surface structure

  3 to 6 months after operation

• Vascular repair index

  3 to 6 months after operation

Other Outcomes (3)

• Blood lipid level：Include LDL、HDL、LDL 、HDL

  Before surgery 、One day after operation、 3 months after operation、 6 months after operation

• Biological indicators：hs-CRP（mg/L）

  Before surgery 、One day after operation、 3 months after operation、 6 months after operation

• Biological indicators：PTX-3、VCAM-1、MMP-9

  Before surgery 、One day after operation、 3 months after operation、 6 months after operation

Study Arms (3)

OCT guided 3-month follow-up group

EXPERIMENTAL

OCT guided the operation, and OCT reexamined 3 months after the operation to evaluate the vascular repair

Device: OCT

3-month follow-up group under the guidance of angiography

NO INTERVENTION

Coronary angiography guides the operation, OCT reexamination 3 months after operation to evaluate vascular repair

6-month follow-up group under the guidance of angiography

NO INTERVENTION

Coronary angiography guides the operation, OCT reexamination 6 months after operation to evaluate vascular repair

Interventions

OCT DEVICE

OCT can provide clear in vivo imaging and evaluate the vascular repair after stent implantation by measuring the optical echo of near-infrared light reflection

Also known as: optical coherence tomography

OCT guided 3-month follow-up group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non pregnant female aged 18-80;
• Patients with unstable angina or acute non ST segment elevation myocardial infarction have been diagnosed clinically;
• The target lesions are primary and in situ coronary lesions. If there are multiple target lesions, they must be located in different epicardial vessels;
• The total length of each target lesion is ≤ 40mm, and the diameter of the target vessel is 2.5mm-4.5mm (visual method);
• The stenosis degree of target lesion ≥ 70% or the stenosis degree of target lesion with evidence of myocardial ischemia ≥ 50% (visual method);
• Each patient is allowed to implant at most 3 homostents (except for salvage implantation of additional stents), and each target lesion is allowed to implant at most 2 homostents;
• Patients with indication of coronary artery bypass surgery;
• Patients who can understand the purpose of this trial, voluntarily participate in and sign the informed consent, have good compliance after discharge, take medicine on time, and are willing to receive optical coherence tomography (OCT) examination and clinical follow-up.

You may not qualify if:

• Any acute ST segment elevation myocardial infarction within 1 month;
• Chronic total occlusion (preoperative Timi Grade 0 blood flow), severe left main coronary artery disease, long disease (disease length \> 40mm), bifurcated disease with double stenting, diameter of disease vessel \> 4.5mm, incomplete optical coherence tomography (OCT) at the lesion site or the disease is not suitable for OCT imaging, bypass vessel disease, visible thrombus in the target vessel, concurrent infection or other inflammatory diseases;
• Severe calcification and tortuosity can not be successfully pre dilated, which is not suitable for stent delivery and expansion;
• Restenosis in stent;
• Patients who had implanted any brand of stent in one year, those who had the possibility of reoperation in one year, and those who had implanted stent for more than one year;
• Hemodynamics or respiratory and circulatory instability have been demonstrated, such as cardiogenic shock, severe heart failure (NYHA III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventriculography);
• The renal function was damaged before operation: EGFR \< 60ml / (min · 1.73m2) or serum creatinine \> 2.5mg/dl (178 μ mol / L);
• Patients with bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or subretinal hemorrhage, history of stroke within half a year, contraindications of antiplatelet agents and anticoagulants cannot receive anticoagulant treatment;
• Allergic to aspirin, clopidogrel or tegrelol, statins, heparin, contrast agents, polymers, zoltamox and metals;
• The life expectancy of patients is less than 12 months;
• Those who have participated in clinical trials of other drugs or medical devices before being selected but failed to reach the time limit of main research end point;
• The researcher judges that the patient's compliance is poor and is unable to complete the study as required, unwilling or unable to provide written informed consent;
• Heart transplant patients;
• There are unstable arrhythmias, such as high-risk ventricular premature beats and ventricular tachycardia;
• Because the tumor needs chemotherapy within 30 days;

Sponsors & Collaborators

• Xuzhou Third People's Hospital: lead
• Shandong Jiwei Medical Products Co., Ltd: collaborator

Study Sites (2)

Xuzhou Third People's Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Peixian Guotai hospital

Xuzhou, Jiangsu, 221600, China

RECRUITING

Related Publications (8)

• Iliescu CA, Cilingiroglu M, Giza DE, Rosales O, Lebeau J, Guerrero-Mantilla I, Lopez-Mattei J, Song J, Silva G, Loyalka P, Paixao ARM, Yusuf SW, Perin E, Anderson VH, Marmagkiolis K. "Bringing on the light" in a complex clinical scenario: Optical coherence tomography-guided discontinuation of antiplatelet therapy in cancer patients with coronary artery disease (PROTECT-OCT registry). Am Heart J. 2017 Dec;194:83-91. doi: 10.1016/j.ahj.2017.08.015. Epub 2017 Aug 23.

  PMID: 29223438 RESULT

• Shlofmitz E, Garcia-Garcia HM. The Role of OCT Guidance for Antiplatelet Therapy. Cardiovasc Revasc Med. 2018 Oct;19(7 Pt A):733-734. doi: 10.1016/j.carrev.2018.09.015. No abstract available.

  PMID: 30420093 RESULT

• Laine M, Dabry T, Combaret N, Motreff P, Puymirat E, Paganelli F, Thuny F, Cautela J, Peyrol M, Mancini J, Lemesle G, Bonello L. OCT Analysis of Very Early Strut Coverage of the Synergy Stent in Non-ST Segment Elevation Acute Coronary Syndrome Patients. J Invasive Cardiol. 2019 Jan;31(1):10-14. doi: 10.25270/jic/18.00274. Epub 2018 Nov 11.

  PMID: 30418164 RESULT

• Won H, Shin DH, Kim BK, Mintz GS, Kim JS, Ko YG, Choi D, Jang Y, Hong MK. Optical coherence tomography derived cut-off value of uncovered stent struts to predict adverse clinical outcomes after drug-eluting stent implantation. Int J Cardiovasc Imaging. 2013 Aug;29(6):1255-63. doi: 10.1007/s10554-013-0223-9. Epub 2013 Apr 25.

  PMID: 23615849 RESULT

• Adriaenssens T, Joner M, Godschalk TC, Malik N, Alfonso F, Xhepa E, De Cock D, Komukai K, Tada T, Cuesta J, Sirbu V, Feldman LJ, Neumann FJ, Goodall AH, Heestermans T, Buysschaert I, Hlinomaz O, Belmans A, Desmet W, Ten Berg JM, Gershlick AH, Massberg S, Kastrati A, Guagliumi G, Byrne RA; Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort (PRESTIGE) Investigators. Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis: A Report of the PRESTIGE Consortium (Prevention of Late Stent Thrombosis by an Interdisciplinary Global European Effort). Circulation. 2017 Sep 12;136(11):1007-1021. doi: 10.1161/CIRCULATIONAHA.117.026788. Epub 2017 Jul 18.

  PMID: 28720725 RESULT

• Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.

  PMID: 30827782 RESULT

• Lee BK, Kim JS, Lee OH, Min PK, Yoon YW, Hong BK, Shin DH, Kang TS, Kim BO, Cho DK, Jeon DW, Woo SI, Choi S, Kim YH, Kang WC, Kim S, Kim BK, Hong MK, Jang Y, Kwon HM. Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy. EuroIntervention. 2018 Mar 20;13(16):1923-1930. doi: 10.4244/EIJ-D-17-00792.

  PMID: 29104179 RESULT

• Zhu YX, Liang L, Parasa R, Li Z, Li Q, Chang S, Ma WR, Feng SL, Wang Y, Xu B, Bourantas CV, Zhang YJ. 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. Front Cardiovasc Med. 2023 Feb 23;10:1003546. doi: 10.3389/fcvm.2023.1003546. eCollection 2023.

  PMID: 36910518 DERIVED

MeSH Terms

Conditions

Angina, Unstable

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• yaojun zhang, Doctorate

  Head of Cardiology Department of Xuzhou Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

huang

CONTACT

+86-13685102194; 13685102194@163.com

li

CONTACT

+86-13813297135; 13813297135@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 5, 2020
• Study Start: October 28, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)