Study of Coronary Plaque Rupture in Heart Attack Following Surgery Using Optical Coherence Tomography (OCT)
NCT ID: NCT01555177
Last Updated: 2014-11-04
Study Results
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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UNKNOWN
60 participants
OBSERVATIONAL
2012-04-30
2015-02-28
Brief Summary
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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):
1. non-surgery related heart attack patients
2. 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.
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Detailed Description
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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
1. To identify features of acute plaque rupture in peri-operative myocardial infarction (POMI)
2. 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
1\. 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Non-surgery related NSTEMI patients
Patients with NSTEMI undergoing cardiac catheterization within 72 hours of symptom onset.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Referred to coronary angiography with the view of revascularisation
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Victar Hsieh
OTHER
Responsible Party
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Victar Hsieh
Interventional fellow
Principal Investigators
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Victar Hsieh, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Services
Tej Sheth, BArts SC MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Services
Locations
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Hamilton General Hospital
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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12-099
Identifier Type: -
Identifier Source: org_study_id
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