Study of Coronary Plaque Rupture in Heart Attack Following Surgery Using Optical Coherence Tomography (OCT)

NCT01555177 | Unknown DMC

• 1 other identifier: 12-099
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.non-surgery related heart attack patients
2. 2.patients who suffered from a heart attack following an operation.

Conditions

Peri-operative Myocardial Infarction; Non-ST Elevation Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (1)

• Other features OCT features of atherosclerotic plaques.

  Day 1

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victar Hsieh: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Victar Hsieh, MBBS PhD

  Hamilton Health Services

  PRINCIPAL INVESTIGATOR

• Tej Sheth, BArts SC MD

  Hamilton Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victar Hsieh, MBBS PhD

CONTACT

1-905-527-4322; victarhsieh@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional fellow

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 15, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

CA (1)