Clinical trial NCT02639962: Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study
Official title: Characteristics of Culprit Lesion and Changes in Plaque Composition During Follow up in NSTEMI. A Dual Energy Cardiac CT Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Arteriosclerosis
Keywords: culprit lesion
arteriosclerosis
cardiac CT
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with verified NSTEMI and Patients with SAP

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.

Eligibility 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

Primary outcomes:
measure: Description and characteristics of culprit lesion by DECT. (z-value)
timeFrame: 72 hours
Secondary outcomes:
measure: Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue
timeFrame: 72 hours
measure: Measure the volume of the culprit lesion
timeFrame: 72 hours
measure: Measure the remodeling index of culprit lesion
timeFrame: 72 hours
measure: Determine the mean Z value for non-culprit plaques containing 1: soft tissue
timeFrame: 72 hours
measure: Determine the mean Z value for non-culprit plaques containing 1: soft tissue
timeFrame: 2 month
measure: Determine the mean Z value for non-culprit plaques containing 1: soft tissue
timeFrame: 1 year
measure: Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
timeFrame: 72 hours
measure: Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
timeFrame: 2 month
measure: Determine the mean Z value for non-culprit plaques containing 2: mixed tissue
timeFrame: 1 year
measure: Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
timeFrame: 72 hours
measure: Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
timeFrame: 2 month
measure: Determine the mean Z value for non-culprit plaques containing 3: calcified tissue
timeFrame: 1 year
measure: changes in non-culprit plaques during 1 year in comparison til patients with stable angina pectoris
timeFrame: 1 year
measure: z value in myocardium related to culprit vessel compared to z-value in myocardium corresponded to non-culprit vessel
timeFrame: 72 hours
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Department of Medical Research, OUH, Svendborg
Study officials:
affiliation: Odense University Hospital, Svendborg Research Department
name: Kenneth Egstrup
role: STUDY_DIRECTOR
References: