Recruiting

Optical Coherence Tomography

Sponsor:

Victar Hsieh

Code:

NCT01555177

Conditions

Peri-operative Myocardial Infarction

Non-ST Elevation Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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 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.

Conditions

Peri-operative Myocardial Infarction

Non-ST Elevation Myocardial Infarction

Study ID

NCT01555177

Start date

Apr, 2012

Status verified date

Nov, 2014

Completion date

Feb, 2015

Anticipated

Primary completion date

Feb, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age over 18
  • Referred to coronary angiography with the view of revascularisation

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Evidence of plaque rupture by OCT imaging [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

More Information

Sponsor

Victar Hsieh

Last update posted

Nov 4, 2014

Last verified

Nov, 2014

Keywords

  • Peri-operative myocardial infarction
  • Non-ST elevation myocardial infarction
  • Optical coherence tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Victar Hsieh on 2014-11-04.