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

NCT02639962 | Unknown DMC

• 1 other identifier: Challenge
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arteriosclerosis

Keywords

culprit lesion; arteriosclerosis; cardiac CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Describe if the culprit lesion contains 1: soft 2: mixed or 3: calcified tissue

  72 hours

• Measure the volume of the culprit lesion

  72 hours

• Measure the remodeling index of culprit lesion

  72 hours

• Determine the mean Z value for non-culprit plaques containing 1: soft tissue

  72 hours

• Determine the mean Z value for non-culprit plaques containing 1: soft tissue

  2 month

Study Arms (2)

NSTEMI

patients hospitalized with NSTEMI diagnosed according to the national Danish guidelines, and are scheduled to coronary angiography.

Radiation: Cardiac CT

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

Interventions

Cardiac CT RADIATION

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

NSTEMI; patients with stable angina pectoris

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with verified NSTEMI and Patients with SAP

You may qualify if:

• Patients with NSTEMI and scheduled to CAG or patients with SAP

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Medical Research, OUH, Svendborg

Svendborg, 5700, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for analyses as hs-CRP, Interleukins and other inflammatory agents.

MeSH Terms

Conditions

Coronary Artery Disease; Arteriosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kenneth Egstrup

  Odense University Hospital, Svendborg Research Department

  STUDY DIRECTOR

Central Study Contacts

Hussam Sheta, M.D

CONTACT

+4526821681; hussam.sheta@rsyd.dk

Jess Lambrechtsen, M.D

CONTACT

jess.lambrechtsen@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 28, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

DK (1)