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

Conditions
Coronary Arteriosclerosis
Interventions
Radiation: Cardiac CT
Registration Number
NCT02639962
Lead Sponsor
Odense University Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
135
Inclusion Criteria
  • Patients with NSTEMI and scheduled to CAG or patients with SAP
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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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
NSTEMICardiac CTpatients hospitalized with NSTEMI diagnosed according to the national Danish guidelines, and are scheduled to coronary angiography.
patients with stable angina pectorisCardiac CTPatients in this group have stable angina symptoms and had verified plaques by earlier CAG or Cardiac CT
Primary Outcome Measures
NameTimeMethod
Description and characteristics of culprit lesion by DECT. (z-value)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 Outcome Measures
NameTimeMethod
Measure the volume of the culprit lesion72 hours

CT software will be automatically able to measure the volume (mm3) og culprit lesion

Determine the mean Z value for non-culprit plaques containing 3: calcified tissue1 year

z-value mg/mm\^3

z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel72 hours

z-value z-value mg/mm\^3

Determine the mean Z value for non-culprit plaques containing 1: soft tissue1 year

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

changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris1 year

z-value z-value mg/mm\^3

Determine the mean Z value for non-culprit plaques containing 2: mixed tissue1 year

z-value mg/mm\^3

Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue72 hours

Visually description if the culprit lesion contain

1: soft tissue (dark area in the scan) 3: calc (white area) or 2: mixed (combined dark and white areas)

Measure the remodeling index of culprit lesion72 hours

CT software will be automatically able to measure the remodeling index in culprit lesion (mm)

Trial Locations

Locations (1)

Department of Medical Research, OUH, Svendborg

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Svendborg, Denmark

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