Acute Coronary SyndromeNCT04444037
Impact of OCT Imaging on Decision Making During PCI in ACS Patients
An observational study of Acute Coronary Syndrome, run by Assiut University at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- OCT-guided PCI
- Type of treatment
- Medical device
- How many people
- 390 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient either underwent PCI with angiography alone or OCT guided and is grouped accordingly
Who may be able to join
- Patients presented with acute coronary syndrome.
- PCI was done to them with stent implantation.
Who cannot join
- Multivessel PCI at the index procedure.
- Patients with ACS due to graft failure post CABG.
- Patients treated with no stent implantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes
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.
Read the detailed description
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
- Acute Coronary Syndrome
- Being tested
- OCT-guided PCI
- Keywords
- OCT, stent implantation
- Medical subject headings
- Acute Coronary Syndrome, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided PCIDevice
using optical coherence tomography imaging to help PCI procedure
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided PCI | PCI procedure was done with intra-coronary imaging OCT. Receives: Device: OCT-guided PCI | |
| Angiography-guided PCI | PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent difference in lumen expansion in stent treated lesion
Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.
Measured: Immediately after the procedure
Secondary outcomes (1)
Clinical outcomes at 1 year follow up
Cardiac death, MI, clinical-driven target-lesion revascularization (TLR), and stroke
Measured: During 1 year following the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Wakayama Medical University
- Responsible party
- Principal investigator, Amir Khalifa Mahfouz Khalifa, Assiut University
- Investigators
- Yehia T Kishk, MD, Study chair, Assiut UniversityHossam H Ali, MD, Study chair, Assiut UniversityAhmed Abdel-Galeel, MD, Study chair, Assiut UniversityTakashi Akasaka, MD, PhD, Study chair, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444037
- Sponsor's protocol ID
- OCT in ACS patients
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Nothing
Publications
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.
PubMed 29384957Kubo 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.
PubMed 29121226Khalifa 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.
PubMed 32307358Kubo 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.
PubMed 29486964Otake 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.
PubMed 32340781TIMI 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.
PubMed 4038784Ali 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.
PubMed 27806900Meneveau 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.
PubMed 27573032
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optical Coherence Tomography Imaging on Decision-making During Percutaneous Coronary Intervention in Patients Presented With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT04444037
- Acronym / sponsor ID
- OCT in ACS patients
- Conditions
- Acute Coronary Syndrome
- Keywords
- OCT, stent implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Wakayama Medical University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided PCI | – | Device: OCT-guided PCIPCI procedure was done with intra-coronary imaging OCT. |
| Angiography-guided PCI | – | –PCI procedure was done without any intra-coronary imaging assistance, guided by angiography alone |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient either underwent PCI with angiography alone or OCT guided and is grouped accordingly
Key inclusion criteria (2 listed)
- Patients presented with acute coronary syndrome.
- PCI was done to them with stent implantation.
Key exclusion criteria (3 listed)
- Multivessel PCI at the index procedure.
- Patients with ACS due to graft failure post CABG.
- Patients treated with no stent implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-guided PCIusing optical coherence tomography imaging to help PCI procedure | Device | OCT-guided PCI |
Primary outcome
Percent difference in lumen expansion in stent treated lesion
Time frame: Immediately after the procedure
Compare residual percent diameter stenosis, percent area stenosis, and acute lumen gain between the two groups.
1 secondary outcome
Clinical outcomes at 1 year follow up
Time frame: During 1 year following the index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Background: PubMed 29384957Wu 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.
- Background: PubMed 29121226Kubo 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.
- Background: PubMed 32307358Khalifa 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.
- Background: PubMed 29486964Kubo 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.
- Background: PubMed 32340781Otake 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.
- Background: PubMed 4038784TIMI 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.
- Background: PubMed 27806900Ali 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.
- Background: PubMed 27573032Meneveau 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.
- Individual participant dataSharing planned: No. Nothing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehia T Kishk, MD study chair
Assiut University
Hossam H Ali, MD study chair
Assiut University
Ahmed Abdel-Galeel, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Assiut University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent difference in lumen expansion in stent treated lesion (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444037, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.