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

NCT ID: NCT02639962

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Coronary Arteriosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NSTEMI

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

Cardiac CT

Intervention Type RADIATION

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

Cardiac CT

Intervention Type RADIATION

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

Interventions

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Cardiac CT

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hussam Mahmoud Sheta

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Egstrup

Role: STUDY_DIRECTOR

Odense University Hospital, Svendborg Research Department

Locations

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Department of Medical Research, OUH, Svendborg

Svendborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Hussam Sheta, M.D

Role: CONTACT

+4526821681

Jess Lambrechtsen, M.D

Role: CONTACT

Facility Contacts

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Hussam Sheta, MD

Role: primary

0045 63202402

Other Identifiers

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Challenge

Identifier Type: -

Identifier Source: org_study_id

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