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Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study (S-20130009)

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ClinicalTrials.gov Identifier: NCT02639962
Recruitment Status : Unknown
Verified May 2017 by Hussam Mahmoud Sheta, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : December 28, 2015
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hussam Mahmoud Sheta, Odense University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Coronary Arteriosclerosis Radiation: Cardiac CT

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 135 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characteristics of Culprit Lesion and Changes in Plaque Composition During Follow up in NSTEMI. A Dual Energy Cardiac CT Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
NSTEMI
patients hospitalized with NSTEMI diagnosed according to the national Danish guidelines, and are scheduled to coronary angiography.
 Radiation: Cardiac CT
Cardiac CT before the CAG, and follow up after 2 month and 12 month
patients with stable angina pectoris
Patients in this group have stable angina symptoms and had verified plaques by earlier CAG or Cardiac CT
 Radiation: Cardiac CT
Cardiac CT before the CAG, and follow up after 2 month and 12 month


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue [ Time Frame: 72 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)


  2. Measure the volume of the culprit lesion [ Time Frame: 72 hours ]
    CT software will be automatically able to measure the volume (mm3) og culprit lesion

  3. Measure the remodeling index of culprit lesion [ Time Frame: 72 hours ]
    CT software will be automatically able to measure the remodeling index in culprit lesion (mm)

  4. Determine the mean Z value for non-culprit plaques containing 1: soft tissue [ Time Frame: 72 hours ]
    measure 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

  5. Determine the mean Z value for non-culprit plaques containing 1: soft tissue [ Time Frame: 2 month ]
    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

  6. Determine the mean Z value for non-culprit plaques containing 1: soft tissue [ Time Frame: 1 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

  7. Determine the mean Z value for non-culprit plaques containing 2: mixed tissue [ Time Frame: 72 hours ]
    z-value mg/mm^3

  8. Determine the mean Z value for non-culprit plaques containing 2: mixed tissue [ Time Frame: 2 month ]
    z-value mg/mm^3

  9. Determine the mean Z value for non-culprit plaques containing 2: mixed tissue [ Time Frame: 1 year ]
    z-value mg/mm^3

  10. Determine the mean Z value for non-culprit plaques containing 3: calcified tissue [ Time Frame: 72 hours ]
    z-value mg/mm^3

  11. Determine the mean Z value for non-culprit plaques containing 3: calcified tissue [ Time Frame: 2 month ]
    z-value mg/mm^3

  12. Determine the mean Z value for non-culprit plaques containing 3: calcified tissue [ Time Frame: 1 year ]
    z-value mg/mm^3

  13. changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris [ Time Frame: 1 year ]
    z-value z-value mg/mm^3

  14. z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel [ Time Frame: 72 hours ]
    z-value z-value mg/mm^3


Biospecimen Retention:   Samples Without DNA
Blood samples for analyses as hs-CRP, Interleukins and other inflammatory agents.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with verified NSTEMI and Patients with SAP
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639962


Contacts
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Contact: Hussam Sheta, M.D +4526821681 hussam.sheta@rsyd.dk
Contact: Jess Lambrechtsen, M.D jess.lambrechtsen@rsyd.dk

Locations
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Denmark
Department of Medical Research, OUH, Svendborg Recruiting
Svendborg, Denmark, 5700
Contact: Hussam Sheta, MD    0045 63202402      
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Director: Kenneth Egstrup Odense University Hospital, Svendborg Research Department
More Information
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Responsible Party: Hussam Mahmoud Sheta, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02639962    
Other Study ID Numbers: Challenge
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by Hussam Mahmoud Sheta, Odense University Hospital:
culprit lesion
arteriosclerosis
cardiac CT
Additional relevant MeSH terms:
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Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases