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Clinical Trials/NCT02639962
NCT02639962
Unknown
N/A

Characteristics of Culprit Lesion and Changes in Plaque Composition During Follow up in NSTEMI. A Dual Energy Cardiac CT Study

Odense University Hospital1 site in 1 country135 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Arteriosclerosis
Sponsor
Odense University Hospital
Enrollment
135
Locations
1
Primary Endpoint
Description and characteristics of culprit lesion by DECT. (z-value)
Last Updated
8 years ago

Overview

Brief Summary

Identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology.

In this study the investigators will investigate culprit lesion in patients with NSTEMI and the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe and identify plaques that may be vulnerable. The investigators will also describe changes in characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a matching group of stable angina pectoris (SAP) patients.

Detailed Description

Patients with verified NSTEMI undergo contrast-enhanced coronary DECT before conventional coronary angiography (CAG), and DECT characteristics of the culprit lesion will be determined. All Non-culprit lesions will be observed during 2 month and 1 year follow up characteristics and changes in plaque composition, volume and core content will be assessed. Patients with SAP undergo a baseline DECT similar to NSTEMI group. Because the expected change in coronary plaques in SAP group is minimal, there is no need for follow up at 2 month.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hussam Mahmoud Sheta

MD

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with NSTEMI and scheduled to CAG or patients with SAP

Exclusion Criteria

  • Not suitable to undergo CT with contrast agent:
  • Known allergy-like reactions to contrast or Claustrophobia
  • Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CT
  • Known renal failure/insufficiency or s-creatinin\> 140 µmol/L.
  • Severe/symptomatic thyrotoxicosis
  • pacemaker

Outcomes

Primary Outcomes

Description and characteristics of culprit lesion by DECT. (z-value)

Time Frame: 72 hours

measure the z-value for the culprit lesion, by marking the culprit lesion with a region of interest (ROI) and the DECT will calculate the mean z-value by mg/mm\^3 in the marked ROI

Secondary Outcomes

  • Measure the volume of the culprit lesion(72 hours)
  • Determine the mean Z value for non-culprit plaques containing 3: calcified tissue(1 year)
  • z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel(72 hours)
  • Determine the mean Z value for non-culprit plaques containing 1: soft tissue(1 year)
  • changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris(1 year)
  • Determine the mean Z value for non-culprit plaques containing 2: mixed tissue(1 year)
  • Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue(72 hours)
  • Measure the remodeling index of culprit lesion(72 hours)

Study Sites (1)

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