Myocardial InfarctionOCTAMINCT03593928
Optical Coherence Tomography Examination in Acute Myocardial Infarction
An observational study of Myocardial Infarction and Optical Coherence Tomography, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Optical Coherence Tomography
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2017to 29 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (age ≥18 years) who presented with STEMI and underwent emergent procedures were prospectively screened for OCT examination of the culprit lesion.
Who may be able to join
- Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted >30 min, ST-segment elevation >0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)
- Age ≥18 years
- Provide written informed consent
Who cannot join
- Cardiac shock
- History of coronary artery bypass graft
- Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion
- Inability to obtain Thrombolysis in myocardial infarction flow grade ≥ 2
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Hongbing Yan, MD, (0086)10+88322281, bcc_ami@126.com
Yu Tan, PhD, (0086)10+88322287, fuwaity@126.com
About this study
Official title: Pre-intervention and Post-intervention Optical Coherence Tomography Examination for Culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction
Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.
Read the detailed description
Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.
Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.
In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.
- Keywords
- biomarker, plaque morphology
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
culprit lesion morphology as assessed by OCT
plaque rupture, plaque erosion or calcified nodule
Measured: 1 day (pre-intervention OCT examination of culprit lesion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start29 Mar 2017
- Primary completion29 Mar 2020 (estimated)
- Study completion29 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, hongbing_yan, China National Center for Cardiovascular Diseases
- Investigators
- Hongbing Yan, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593928
- Sponsor's protocol ID
- 2018-0710
- Acronym
- OCTAMI
- Status last verified
- May 2019
- First submitted
- 11 Jul 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Chen R, Zhou J, Wang Y, Zhao X, Liu C, Zhou P, Chen Y, Song L, Yan S, Yan H, Zhao H. Associations of Culprit Vessel Size and Plaque Characteristics in Patients with ST-Segment Elevation Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 29;24(7):186. doi: 10.31083/j.rcm2407186. eCollection 2023 Jul.
PubMed 39077009Zhao X, Zhao H, Chen R, Li J, Zhou J, Li N, Yan S, Liu C, Zhou P, Chen Y, Song L, Yan H. A Combined Measure of the Triglyceride Glucose Index and Trimethylamine N-Oxide in Risk Stratification of ST-Segment Elevation Myocardial Infarction Patients with High-Risk Plaque Features Defined by Optical Coherence Tomography: A Substudy of the OCTAMI Registry Study. Vasc Health Risk Manag. 2024 Mar 29;20:141-155. doi: 10.2147/VHRM.S443742. eCollection 2024.
PubMed 38567028Li N, Zhou J, Chen R, Zhao X, Li J, Zhou P, Liu C, Chen Y, Wang Y, Song L, Yan S, Zhao H, Yan H. Prognostic impacts of diabetes status and lipoprotein(a) levels in patients with ST-segment elevation myocardial infarction: a prospective cohort study. Cardiovasc Diabetol. 2023 Jun 26;22(1):151. doi: 10.1186/s12933-023-01881-w.
PubMed 37365608Li N, Chen R, Li J, Zhao X, Wang Y, Zhou J, Zhou P, Liu C, Chen Y, Song L, Yan S, Zhao H, Yan H. Prognostic significance of serial N-terminal pro-B-type natriuretic peptide levels in patients with acute myocardial infarction: A prospective study. Am Heart J. 2023 Aug;262:90-99. doi: 10.1016/j.ahj.2023.04.015. Epub 2023 Apr 26.
PubMed 37116605Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Prognostic value of characteristics of plaque combined with residual syntax score among patients with STEMI undergoing primary PCI: an intravascular optical coherence tomography study. Thromb J. 2021 Nov 12;19(1):85. doi: 10.1186/s12959-021-00329-z.
PubMed 34772417Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Plasma Pentraxin-3 Combined with Plaque Characteristics Predict Cardiovascular Risk in ST-Segment Elevated Myocardial Infarction: An Optical Coherence Tomography Study. J Inflamm Res. 2021 Sep 2;14:4409-4419. doi: 10.2147/JIR.S330600. eCollection 2021.
PubMed 34511975Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Residual SYNTAX Score in Relation to Coronary Culprit Plaque Characteristics and Cardiovascular Risk in ST Segment Elevation Myocardial Infarction: an Intravascular Optical Coherence Tomography Study. J Cardiovasc Transl Res. 2022 Feb;15(1):75-83. doi: 10.1007/s12265-021-10152-6. Epub 2021 Jul 9.
PubMed 34244969Zhou J, Chen R, Liu C, Zhou P, Li J, Wang Y, Zhao X, Zhao H, Song L, Yan H. Associations of NETs with inflammatory risk and atherosclerotic severity in ST-segment elevation myocardial infarction. Thromb Res. 2021 Jul;203:5-11. doi: 10.1016/j.thromres.2021.04.015. Epub 2021 Apr 19.
PubMed 33894474Li J, Tan Y, Zhou P, Liu C, Zhao H, Song L, Zhou J, Chen R, Wang Y, Zhao X, Chen Y, Yan H. Association of Trimethylamine N-Oxide Levels and Calcification in Culprit Lesion Segments in Patients With ST-Segment-Elevation Myocardial Infarction Evaluated by Optical Coherence Tomography. Front Cardiovasc Med. 2021 Feb 24;8:628471. doi: 10.3389/fcvm.2021.628471. eCollection 2021.
PubMed 33718451Zhou J, Yu S, Tan Y, Zhou P, Liu C, Sheng Z, Li J, Chen R, Zhao S, Yan H. Trimethylamine N-Oxide Was Not Associated With 30-Day Left Ventricular Systolic Dysfunction in Patients With a First Anterior ST-Segment Elevation Myocardial Infarction After Primary Revascularization: A Sub-analysis From an Optical Coherence Tomography Registry. Front Cardiovasc Med. 2020 Dec 23;7:613684. doi: 10.3389/fcvm.2020.613684. eCollection 2020.
PubMed 33426008Zhou J, Sheng Z, Liu C, Zhou P, Li J, Chen R, Song L, Zhao H, Yan H. Association between Admission Hyperglycemia and Culprit Lesion Characteristics in Nondiabetic Patients with Acute Myocardial Infarction: An Intravascular Optical Coherence Tomography Study. J Diabetes Res. 2020 Jun 20;2020:1763567. doi: 10.1155/2020/1763567. eCollection 2020.
PubMed 32685552Sheng Z, Zhou P, Liu C, Li J, Chen R, Zhou J, Song L, Zhao H, Yan H. Relationships of coronary culprit-plaque characteristics with duration of diabetes mellitus in acute myocardial infarction: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2019 Oct 19;18(1):136. doi: 10.1186/s12933-019-0944-8.
PubMed 31629406Tan Y, Sheng Z, Zhou P, Liu C, Zhao H, Song L, Li J, Zhou J, Chen Y, Wang L, Qian H, Sun Z, Qiao S, Xu B, Gao R, Yan H. Plasma Trimethylamine N-Oxide as a Novel Biomarker for Plaque Rupture in Patients With ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 Jan;12(1):e007281. doi: 10.1161/CIRCINTERVENTIONS.118.007281.
PubMed 30599768
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-intervention and Post-intervention Optical Coherence Tomography Examination for Culprit Lesion in Patients With ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03593928
- Acronym / sponsor ID
- OCTAMI / 2018-0710
- Keywords
- biomarker, plaque morphology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 29 Mar 2020 (estimated)
- Study completion
- 29 Apr 2020 (estimated)
- First posted
- 20 Jul 2018 (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.
Different plaque morphology may have an important effect on the prognosis of acute myocardial infarction (AMI), as recent studies show that patients with plaque rupture have a significantly higher risk of cardiac events compared with those with plaque erosion. The primary purpose of this study is to find risk factors and biomarkers for different culprit lesion morphology to perform accurate risk stratification and determine an appropriate treatment strategy for patients with AMI.
Detailed description
Acute myocardial infarction (AMI), which results from coronary artery occlusion due to thrombosis, remains the leading cause of death and disability worldwide. Pathological studies have demonstrated that plaque rupture accompanied by subsequent thrombus formation is the main mechanism responsible for AMI, accounting for approximately two thirds of cases; the remaining approximately one third of cases are the result of plaque erosion. Moreover, previous studies showed that the risk of cardiovascular events is significantly higher in patients with plaque rupture compared to those with plaque erosion. The EROSION study suggested that in patients with acute coronary syndrome presenting with plaque erosion, conservative treatment with anti-thrombotic therapy may be a reasonable option instead of stents implantation. Therefore, it is important to differentiate between the culprit morphologies in order to perform an accurate risk stratification and determine a personalized treatment strategy with the goal to improve the prognosis of patients with AMI.
Optical coherence tomography (OCT), a newly developed high resolution near infrared light-based intravascular imaging modality, can visualize the microstructure of atherosclerotic plaques such as the fibrotic cap, lipid pool, thrombi, and so on, and has been considered as the golden standard for differentiating plaque morphology in vivo.
In this study, we aimed to find risk factors and biomarkers for culprit lesion morphology as assessed by OCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (age ≥18 years) who presented with STEMI and underwent emergent procedures were prospectively screened for OCT examination of the culprit lesion.
Key inclusion criteria (3 listed)
- Patients with ST-segment elevation myocardial infarction (defined as continuous chest pain lasted >30 min, ST-segment elevation >0.1 mV in at least two contiguous leads or new left bundle-branch block on the 18-lead electrocardiogram (ECG), and an elevated troponin I level)
- Age ≥18 years
- Provide written informed consent
Key exclusion criteria (4 listed)
- Cardiac shock
- History of coronary artery bypass graft
- Left main diseases, extremely tortuous or heavily calcified vessels, or chronic total occlusion
- Inability to obtain Thrombolysis in myocardial infarction flow grade ≥ 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
culprit lesion morphology as assessed by OCT
Time frame: 1 day (pre-intervention OCT examination of culprit lesion)
plaque rupture, plaque erosion or calcified nodule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Derived from this study: PubMed 39077009Li J, Chen R, Zhou J, Wang Y, Zhao X, Liu C, Zhou P, Chen Y, Song L, Yan S, Yan H, Zhao H. Associations of Culprit Vessel Size and Plaque Characteristics in Patients with ST-Segment Elevation Myocardial Infarction. Rev Cardiovasc Med. 2023 Jun 29;24(7):186. doi: 10.31083/j.rcm2407186. eCollection 2023 Jul.
- Derived from this study: PubMed 38567028Zhao X, Zhao H, Chen R, Li J, Zhou J, Li N, Yan S, Liu C, Zhou P, Chen Y, Song L, Yan H. A Combined Measure of the Triglyceride Glucose Index and Trimethylamine N-Oxide in Risk Stratification of ST-Segment Elevation Myocardial Infarction Patients with High-Risk Plaque Features Defined by Optical Coherence Tomography: A Substudy of the OCTAMI Registry Study. Vasc Health Risk Manag. 2024 Mar 29;20:141-155. doi: 10.2147/VHRM.S443742. eCollection 2024.
- Derived from this study: PubMed 37365608Li N, Zhou J, Chen R, Zhao X, Li J, Zhou P, Liu C, Chen Y, Wang Y, Song L, Yan S, Zhao H, Yan H. Prognostic impacts of diabetes status and lipoprotein(a) levels in patients with ST-segment elevation myocardial infarction: a prospective cohort study. Cardiovasc Diabetol. 2023 Jun 26;22(1):151. doi: 10.1186/s12933-023-01881-w.
- Derived from this study: PubMed 37116605Li N, Chen R, Li J, Zhao X, Wang Y, Zhou J, Zhou P, Liu C, Chen Y, Song L, Yan S, Zhao H, Yan H. Prognostic significance of serial N-terminal pro-B-type natriuretic peptide levels in patients with acute myocardial infarction: A prospective study. Am Heart J. 2023 Aug;262:90-99. doi: 10.1016/j.ahj.2023.04.015. Epub 2023 Apr 26.
- Derived from this study: PubMed 34772417Zhao X, Wang Y, Chen R, Li J, Zhou J, Liu C, Zhou P, Sheng Z, Chen Y, Song L, Zhao H, Yan H. Prognostic value of characteristics of plaque combined with residual syntax score among patients with STEMI undergoing primary PCI: an intravascular optical coherence tomography study. Thromb J. 2021 Nov 12;19(1):85. doi: 10.1186/s12959-021-00329-z.
- Derived from this study: PubMed 34511975Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Plasma Pentraxin-3 Combined with Plaque Characteristics Predict Cardiovascular Risk in ST-Segment Elevated Myocardial Infarction: An Optical Coherence Tomography Study. J Inflamm Res. 2021 Sep 2;14:4409-4419. doi: 10.2147/JIR.S330600. eCollection 2021.
- Derived from this study: PubMed 34244969Wang Y, Zhao X, Zhou P, Liu C, Sheng Z, Li J, Zhou J, Chen R, Chen Y, Song L, Zhao H, Yan H. Residual SYNTAX Score in Relation to Coronary Culprit Plaque Characteristics and Cardiovascular Risk in ST Segment Elevation Myocardial Infarction: an Intravascular Optical Coherence Tomography Study. J Cardiovasc Transl Res. 2022 Feb;15(1):75-83. doi: 10.1007/s12265-021-10152-6. Epub 2021 Jul 9.
- Derived from this study: PubMed 33894474Zhou J, Chen R, Liu C, Zhou P, Li J, Wang Y, Zhao X, Zhao H, Song L, Yan H. Associations of NETs with inflammatory risk and atherosclerotic severity in ST-segment elevation myocardial infarction. Thromb Res. 2021 Jul;203:5-11. doi: 10.1016/j.thromres.2021.04.015. Epub 2021 Apr 19.
- Derived from this study: PubMed 33718451Li J, Tan Y, Zhou P, Liu C, Zhao H, Song L, Zhou J, Chen R, Wang Y, Zhao X, Chen Y, Yan H. Association of Trimethylamine N-Oxide Levels and Calcification in Culprit Lesion Segments in Patients With ST-Segment-Elevation Myocardial Infarction Evaluated by Optical Coherence Tomography. Front Cardiovasc Med. 2021 Feb 24;8:628471. doi: 10.3389/fcvm.2021.628471. eCollection 2021.
- Derived from this study: PubMed 33426008Zhou J, Yu S, Tan Y, Zhou P, Liu C, Sheng Z, Li J, Chen R, Zhao S, Yan H. Trimethylamine N-Oxide Was Not Associated With 30-Day Left Ventricular Systolic Dysfunction in Patients With a First Anterior ST-Segment Elevation Myocardial Infarction After Primary Revascularization: A Sub-analysis From an Optical Coherence Tomography Registry. Front Cardiovasc Med. 2020 Dec 23;7:613684. doi: 10.3389/fcvm.2020.613684. eCollection 2020.
- Derived from this study: PubMed 32685552Zhou J, Sheng Z, Liu C, Zhou P, Li J, Chen R, Song L, Zhao H, Yan H. Association between Admission Hyperglycemia and Culprit Lesion Characteristics in Nondiabetic Patients with Acute Myocardial Infarction: An Intravascular Optical Coherence Tomography Study. J Diabetes Res. 2020 Jun 20;2020:1763567. doi: 10.1155/2020/1763567. eCollection 2020.
- Derived from this study: PubMed 31629406Sheng Z, Zhou P, Liu C, Li J, Chen R, Zhou J, Song L, Zhao H, Yan H. Relationships of coronary culprit-plaque characteristics with duration of diabetes mellitus in acute myocardial infarction: an intravascular optical coherence tomography study. Cardiovasc Diabetol. 2019 Oct 19;18(1):136. doi: 10.1186/s12933-019-0944-8.
- Individual participant dataSharing planned: No
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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.
Hongbing Yan, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
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 Myocardial Infarction and Optical Coherence Tomography, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 May 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbing Yan, MD (008601088322281, bcc_ami@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culprit lesion morphology as assessed by OCT (time frame: 1 day (pre-intervention OCT examination of culprit lesion)). 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 NCT03593928, which also lists 13 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 16 May 2019.