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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02639962
Acronym
S-20130009
Enrollment
135
Registered
2015-12-28
Start date
2014-09-30
Completion date
2017-09-30
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arteriosclerosis

Keywords

culprit lesion, arteriosclerosis, cardiac CT

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.

Interventions

RADIATIONCardiac CT

Cardiac CT before the CAG, and follow up after 2 month and 12 month

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description and characteristics of culprit lesion by DECT. (z-value)72 hoursmeasure 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

MeasureTime frameDescription
Measure the volume of the culprit lesion72 hoursCT software will be automatically able to measure the volume (mm3) og culprit lesion
Measure the remodeling index of culprit lesion72 hoursCT software will be automatically able to measure the remodeling index in culprit lesion (mm)
Determine the mean Z value for non-culprit plaques containing 1: soft tissue72 hoursmeasure the z-value for the culprit lesion, by marking the lesion with a ROI and the DECT will calculate the mean z-value in the marked ROI
Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue72 hoursVisually 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)
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue72 hoursz-value mg/mm\^3
changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris1 yearz-value z-value mg/mm\^3
z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel72 hoursz-value z-value mg/mm\^3
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue72 hoursz-value mg/mm\^3

Countries

Denmark

Contacts

Primary ContactHussam Sheta, M.D
hussam.sheta@rsyd.dk+4526821681
Backup ContactJess Lambrechtsen, M.D
jess.lambrechtsen@rsyd.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026