Impact of OCT Imaging on Decision Making During PCI in ACS Patients

NCT ID: NCT04444037

Last Updated: 2020-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-04-30

Brief Summary

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Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.

Detailed Description

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OCT can be used in acute coronary syndrome (ACS). ACS has more complex culprit lesion morphologies and larger extent of coronary atherosclerosis compared with stable coronary artery disease. The detailed vascular information obtained by OCT may impact PCI in ACS, and which may improve acute results and late outcomes of PCI. Stent expansion immediately after PCI is a strong predictor of late outcomes of PCI, and it is associated with late clinical outcomes in many previous trials.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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OCT-guided PCI

PCI procedure was done with intra-coronary imaging OCT.

OCT-guided PCI

Intervention Type DEVICE

using optical coherence tomography imaging to help PCI procedure

Angiography-guided PCI

PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone

No interventions assigned to this group

Interventions

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OCT-guided PCI

using optical coherence tomography imaging to help PCI procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients presented with acute coronary syndrome.
* PCI was done to them with stent implantation.

Exclusion Criteria

* Multivessel PCI at the index procedure.
* Patients with ACS due to graft failure post CABG.
* Patients treated with no stent implantation.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wakayama Medical University

OTHER

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amir Khalifa Mahfouz Khalifa

Principle investigator, Cardiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yehia T Kishk, MD

Role: STUDY_CHAIR

Assiut University

Hossam H Ali, MD

Role: STUDY_CHAIR

Assiut University

Ahmed Abdel-Galeel, MD

Role: STUDY_CHAIR

Assiut University

Takashi Akasaka, MD, PhD

Role: STUDY_CHAIR

Wakayama Medical University

Locations

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Wakayama Medical University

Wakayama, , Japan

Site Status

Countries

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Japan

References

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Wu S, Liu W, Guo Y, Zeng Y, Zhou Z, Zhao Y, Liu Y, Shi D, Wang Z, Ge H, Wang J, Jin P, Zhou Y. The impact of acute coronary syndrome on late drug-eluting stents restenosis: Insights from optical coherence tomography. Medicine (Baltimore). 2017 Dec;96(52):e9515. doi: 10.1097/MD.0000000000009515.

Reference Type BACKGROUND
PMID: 29384957 (View on PubMed)

Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.

Reference Type BACKGROUND
PMID: 29121226 (View on PubMed)

Khalifa AKM, Kubo T, Ino Y, Terada K, Emori H, Higashioka D, Katayama Y, Takahata M, Shimamura K, Shiono Y, Matsuo Y, Tanaka A, Hozumi T, Akasaka T. Optical Coherence Tomography Comparison of Percutaneous Coronary Intervention Among Plaque Rupture, Erosion, and Calcified Nodule in Acute Myocardial Infarction. Circ J. 2020 May 25;84(6):911-916. doi: 10.1253/circj.CJ-20-0014. Epub 2020 Apr 18.

Reference Type BACKGROUND
PMID: 32307358 (View on PubMed)

Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Ino Y, Kitabata H, Shimokawa T, Akasaka T. Comparison between Optical COherence tomography guidance and Angiography guidance in percutaneous coronary intervention (COCOA): Study protocol for a randomized controlled trial. J Cardiol. 2018 Aug;72(2):170-175. doi: 10.1016/j.jjcc.2018.01.005. Epub 2018 Mar 2.

Reference Type BACKGROUND
PMID: 29486964 (View on PubMed)

Otake H, Kubo T, Shinke T, Hibi K, Tanaka S, Ishida M, Kataoka T, Takaya T, Iwasaki M, Sonoda S, Ioji T, Akasaka T. OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial. J Cardiol. 2020 Sep;76(3):317-321. doi: 10.1016/j.jjcc.2020.03.010. Epub 2020 Apr 24.

Reference Type BACKGROUND
PMID: 32340781 (View on PubMed)

TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.

Reference Type BACKGROUND
PMID: 4038784 (View on PubMed)

Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.

Reference Type BACKGROUND
PMID: 27806900 (View on PubMed)

Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

Reference Type BACKGROUND
PMID: 27573032 (View on PubMed)

Other Identifiers

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OCT in ACS patients

Identifier Type: -

Identifier Source: org_study_id

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