Peri-operative Myocardial InfarctionOPTIMUSNCT01555177
Study of Coronary Plaque Rupture in Heart Attack Following Surgery Using Optical Coherence Tomography (OCT)
An observational study of Peri-operative Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Victar Hsieh at 1 site in Canada.
Trial summary
Background It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of the coronary artery, resulting in blood clots which impede blood flow. Currently, the investigators do not know whether heart attacks in patients who had a recent surgery are caused by the same disease process as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-operative Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Feb 2015
- 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: NSTEMI and peri-operative MI patients will be screened in the catheterisation laboratory. In addition, peri-operative MI patients will be screened in hospital wards, where patient referral for cardiac catheterisation will be based on clinical indications.
Who may be able to join
- Age over 18
- Referred to coronary angiography with the view of revascularisation
Who cannot join
- ST elevation myocardial infarction
- Shock defined as the systolic blood pressure <90mmHg and tachycardia with heart rate >100 with evidence of systemic organ hypoperfusion.
- Inability to give consent
- Previous coronary artery bypass surgery due to the limited anticipated feasibility of OCT imaging in native vessels of patients with prior bypass grafts.
- PCI with stenting in the previous 6 months due to the elevated risk of stent related complications (thrombosis or restenosis) as the potential cause of the NSTEMI.
- GFR <35 due to need for additional 40-60 cc contrast during OCT imaging.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Tej Sheth, sheth@mcmaster.ca
About this study
Official title: OCT Plaque and Thrombus IMaging in Patients Who Underwent Non-cardiac Surgery
Background
It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of the coronary artery, resulting in blood clots which impede blood flow. Currently, the investigators do not know whether heart attacks in patients who had a recent surgery are caused by the same disease process as those who did not have any surgery. This study will inform the investigators of very vital information about the cause of surgery-related heart attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT). Images will also be taken from heart attack patients who did not have recent surgery, and the two groups will be compared.
Read more
OCT imaging
OCT is a relatively new imaging technology which is much better at taking images of the inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary artery, it will record video images of a length of the artery. These images will take approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of the angiogram procedure is carried out in exactly the same way as it would normally proceed.
The OCT study will provide doctors with new information about the cause of surgery-related heart attacks, and will guide doctors in treating and preventing heart attacks in patients who undergo surgery.
Hypothesis
The investigators hypothesize that features of acute plaque rupture will be more common in patients with non-surgery related heart attacks compared to those which occur following surgery.
Design
Two groups of patients will be recruited(>20 in each group):
- non-surgery related heart attack patients
- patients who suffered from a heart attack following an operation.
Outcome measures
Using OCT, plaque features in coronary arteries of patients with heart attacks from both the surgical and non-surgical groups at the time of coronary angiogram will be compared.
Read the detailed description
The majority of spontaneous non-ST segment elevation myocardial infarctions (NSTEMI) are attributed to rupture of an unstable atherosclerotic plaque in an epicardial coronary artery with thrombus formation. On the other hand, the pathophysiology underlying myocardial infarction following non-cardiac surgery is not well understood. The literature suggests that a significant proportion of myocardial infarctions following surgery may result from decreased myocardial perfusion in the presence of stable coronary artery disease without plaque rupture or thrombus formation.
Intra-coronary Optical Coherence Tomography (OCT) provides superior visualisation of the vascular lumen and structures close to the arterial lumen compared to IVUS, including features of plaque instability, including atherosclerotic plaque contents, fibrous cap thickness, thin cap fibroatheromas (TCFA), macrophage infiltration and calcium (2-10). OCT is therefore an ideal imaging technique to examine the pathophysiology involved in POMI, where features of plaque rupture and thrombus formation can be clearly distinguished from stable plaques.
An improved understanding of the pathophysiology of MI following non-cardiac surgery will guide management more appropriately.
Primary objective
- To identify features of acute plaque rupture in peri-operative myocardial infarction (POMI)
- To compare frequency of acute plaque rupture imaging findings between POMI and non-operative non-ST-elevation myocardial infarction (NSTEMI)
Hypothesis
The investigators hypothesize that features of acute plaque rupture will be more common in patients with non-operative NSTEMI compared to POMI.
Outcome measures
- OCT features of coronary plaque rupture will be obtained at the time of coronary angiography, these features include thin cap fibroatheroma, intramural thrombus and plaque fissuring. OCT data from NSTEMI and POMI patient groups will be compared. Data on other plaque features, including fibrous cap thickness, lipid core, minimum luminal cross-sectional area (CSA), ruptured cavity CSA will also be collected, and compared between the two patient groups.
There will be no clinical follow-up in this study.
- Keywords
- Peri-operative myocardial infarction, Non-ST elevation myocardial infarction, Optical coherence tomography
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peri-operative NSTEMI patients | Patients with POMI undergoing cardiac catheterization within 72 hours of first troponin elevation and within 2 weeks of their non-cardiac surgery. | |
| Non-surgery related NSTEMI patients | Patients with NSTEMI undergoing cardiac catheterization within 72 hours of symptom onset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of plaque rupture by OCT imaging
OCT evidence of plaque rupture, presence of white or red thrombus will be collected at the time of coronary angiography.
Measured: Day 1
Secondary outcomes (1)
Other features OCT features of atherosclerotic plaques.
lFeatures of stable plaques in the coronary artery, including: Lipid core, fibrous cap, thin cap fibroatheroma, thick cap fibroatheroma, minimum luminal cross-sectional area, ruptured cavity CSA.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victar Hsieh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victar Hsieh, Hamilton Health Sciences Corporation
- Investigators
- Victar Hsieh, MBBS PhD, Principal investigator, Hamilton Health ServicesTej Sheth, BArts SC MD, Principal investigator, Hamilton Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555177
- Sponsor's protocol ID
- 12-099
- Acronym
- OPTIMUS
- Status last verified
- Nov 2014
- First submitted
- 9 Mar 2012
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Plaque and Thrombus IMaging in Patients Who Underwent Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT01555177
- Acronym / sponsor ID
- OPTIMUS / 12-099
- Keywords
- Peri-operative myocardial infarction, Non-ST elevation myocardial infarction, Optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Victar HsiehUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 15 Mar 2012 (estimated)
- 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.
Background
It is commonly believed that a heart attack is caused by rupture of a plaque in the wall of the coronary artery, resulting in blood clots which impede blood flow. Currently, the investigators do not know whether heart attacks in patients who had a recent surgery are caused by the same disease process as those who did not have any surgery. This study will inform the investigators of very vital information about the cause of surgery-related heart attacks by taking images of coronary arteries using Optical Coherence Tomography (OCT). Images will also be taken from heart attack patients who did not have recent surgery, and the two groups will be compared.
OCT imaging
OCT is a relatively new imaging technology which is much better at taking images of the inside of the artery. OCT imaging procedure is carried out at the time of scheduled coronary angiogram, where a catheter with a mini-camera at its tip is advanced into the coronary artery, it will record video images of a length of the artery. These images will take approximately 3-4 seconds to obtain. Besides the OCT imaging being performed, the rest of the angiogram procedure is carried out in exactly the same way as it would normally proceed.
The OCT study will provide doctors with new information about the cause of surgery-related heart attacks, and will guide doctors in treating and preventing heart attacks in patients who undergo surgery.
Hypothesis
The investigators hypothesize that features of acute plaque rupture will be more common in patients with non-surgery related heart attacks compared to those which occur following surgery.
Design
Two groups of patients will be recruited(>20 in each group):
- non-surgery related heart attack patients
- patients who suffered from a heart attack following an operation.
Outcome measures
Using OCT, plaque features in coronary arteries of patients with heart attacks from both the surgical and non-surgical groups at the time of coronary angiogram will be compared.
Detailed description
The majority of spontaneous non-ST segment elevation myocardial infarctions (NSTEMI) are attributed to rupture of an unstable atherosclerotic plaque in an epicardial coronary artery with thrombus formation. On the other hand, the pathophysiology underlying myocardial infarction following non-cardiac surgery is not well understood. The literature suggests that a significant proportion of myocardial infarctions following surgery may result from decreased myocardial perfusion in the presence of stable coronary artery disease without plaque rupture or thrombus formation.
Intra-coronary Optical Coherence Tomography (OCT) provides superior visualisation of the vascular lumen and structures close to the arterial lumen compared to IVUS, including features of plaque instability, including atherosclerotic plaque contents, fibrous cap thickness, thin cap fibroatheromas (TCFA), macrophage infiltration and calcium (2-10). OCT is therefore an ideal imaging technique to examine the pathophysiology involved in POMI, where features of plaque rupture and thrombus formation can be clearly distinguished from stable plaques.
An improved understanding of the pathophysiology of MI following non-cardiac surgery will guide management more appropriately.
Primary objective
- To identify features of acute plaque rupture in peri-operative myocardial infarction (POMI)
- To compare frequency of acute plaque rupture imaging findings between POMI and non-operative non-ST-elevation myocardial infarction (NSTEMI)
Hypothesis
The investigators hypothesize that features of acute plaque rupture will be more common in patients with non-operative NSTEMI compared to POMI.
Outcome measures
- OCT features of coronary plaque rupture will be obtained at the time of coronary angiography, these features include thin cap fibroatheroma, intramural thrombus and plaque fissuring. OCT data from NSTEMI and POMI patient groups will be compared. Data on other plaque features, including fibrous cap thickness, lipid core, minimum luminal cross-sectional area (CSA), ruptured cavity CSA will also be collected, and compared between the two patient groups.
There will be no clinical follow-up in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-operative NSTEMI patients | – | –Patients with POMI undergoing cardiac catheterization within 72 hours of first troponin elevation and within 2 weeks of their non-cardiac surgery. |
| Non-surgery related NSTEMI patients | – | –Patients with NSTEMI undergoing cardiac catheterization within 72 hours of symptom onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSTEMI and peri-operative MI patients will be screened in the catheterisation laboratory. In addition, peri-operative MI patients will be screened in hospital wards, where patient referral for cardiac catheterisation will be based on clinical indications.
Key inclusion criteria (2 listed)
- Age over 18
- Referred to coronary angiography with the view of revascularisation
Key exclusion criteria (6 listed)
- ST elevation myocardial infarction
- Shock defined as the systolic blood pressure <90mmHg and tachycardia with heart rate >100 with evidence of systemic organ hypoperfusion.
- Inability to give consent
- Previous coronary artery bypass surgery due to the limited anticipated feasibility of OCT imaging in native vessels of patients with prior bypass grafts.
- PCI with stenting in the previous 6 months due to the elevated risk of stent related complications (thrombosis or restenosis) as the potential cause of the NSTEMI.
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
Evidence of plaque rupture by OCT imaging
Time frame: Day 1
OCT evidence of plaque rupture, presence of white or red thrombus will be collected at the time of coronary angiography.
1 secondary outcome
Other features OCT features of atherosclerotic plaques.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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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.
Victar Hsieh, MBBS PhD principal investigator
Hamilton Health Services
Tej Sheth, BArts SC MD principal investigator
Hamilton Health Services
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 Peri-operative Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Victar Hsieh at 1 site in Canada.
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 6 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 4 Nov 2014. 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 Canada. 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 Victar Hsieh, MBBS PhD (1-905-527-4322, victarhsieh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of plaque rupture by OCT imaging (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2014.