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

Coronary Arteriosclerosis Clinical Trial

— S-20130009  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02639962
• Other study ID #: Challenge
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2015
• Last updated: May 31, 2017
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: Odense University Hospital
• Contact: Hussam Sheta, M.D
• Phone: +4526821681
• Email: hussam.sheta[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Medical Research, OUH, Svendborg	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description and characteristics of culprit lesion by DECT. (z-value)	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	Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue	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
Secondary	Measure the volume of the culprit lesion	CT software will be automatically able to measure the volume (mm3) og culprit lesion	72 hours
Secondary	Measure the remodeling index of culprit lesion	CT software will be automatically able to measure the remodeling index in culprit lesion (mm)	72 hours
Secondary	Determine the mean Z value for non-culprit plaques containing 1: soft tissue	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
Secondary	Determine the mean Z value for non-culprit plaques containing 1: soft tissue	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
Secondary	Determine the mean Z value for non-culprit plaques containing 1: soft tissue	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
Secondary	Determine the mean Z value for non-culprit plaques containing 2: mixed tissue	z-value mg/mm^3	72 hours
Secondary	Determine the mean Z value for non-culprit plaques containing 2: mixed tissue	z-value mg/mm^3	2 month
Secondary	Determine the mean Z value for non-culprit plaques containing 2: mixed tissue	z-value mg/mm^3	1 year
Secondary	Determine the mean Z value for non-culprit plaques containing 3: calcified tissue	z-value mg/mm^3	72 hours
Secondary	Determine the mean Z value for non-culprit plaques containing 3: calcified tissue	z-value mg/mm^3	2 month
Secondary	Determine the mean Z value for non-culprit plaques containing 3: calcified tissue	z-value mg/mm^3	1 year
Secondary	changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris	z-value z-value mg/mm^3	1 year
Secondary	z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel	z-value z-value mg/mm^3	72 hours