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

May 31, 2017 updated by: Hussam Mahmoud Sheta, Odense University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Svendborg, Denmark, 5700
        • Recruiting
        • Department of Medical Research, OUH, Svendborg
        • Contact:
          • Hussam Sheta, MD
          • Phone Number: 0045 63202402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with verified NSTEMI and Patients with SAP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
72 hours
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
72 hours
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)
72 hours
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
72 hours
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
2 month
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
1 year
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time Frame: 72 hours
z-value mg/mm^3
72 hours
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time Frame: 2 month
z-value mg/mm^3
2 month
Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
Time Frame: 1 year
z-value mg/mm^3
1 year
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time Frame: 72 hours
z-value mg/mm^3
72 hours
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time Frame: 2 month
z-value mg/mm^3
2 month
Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
Time Frame: 1 year
z-value mg/mm^3
1 year
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
1 year
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Director: Kenneth Egstrup, Odense University Hospital, Svendborg Research Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 28, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHALLENGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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