Investigation of PET tracers for their ability to determine coronary stenosis at risk for rupture.

Phase 1

• Conditions: The IMP (PET-tracer) will be investigated in patients 24-72 hours after an acute coronary syndrome without excessive enzyme release (CK < 180 U/L) during PET scanning protocol.; MedDRA version: 18.0 Level: LLT Classification code 10066521 Term: Coronary artery disease progression System Organ Class: 100000004849; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-002670-40-NL
• Lead Sponsor: VU University Medical Center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

•Patients with an acute coronary syndrome and accompanying ECG abnormalities (unstable angina / non-ST-elevation myocardial infarction without significant enzyme release (CK < 180 U/L).
•Clinical indication for invasive coronary angiography within 72 hours upon admission based on ESC guidelines pertaining treatment of patients with unstable angina or non-ST segment elevation myocardial infarction.
•Age 35-65 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior cardiac history (e.g. percutaneous coronary intervention, coronary artery bypass surgery, or myocardial infarction)
•History of systemic inflammatory disease
•Cardiac arrhythmia
•Prior medication use (e.g. statins or anti-inflammatory agents)
•Renal failure (estimated glomerular filtration rate < 60 ml/min)
•Refusal or inability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective is to study the feasibility of different PET tracers to detect vulnerable plaques in patients with a recent acute coronary syndrome and co-localize these inflammatory lesions with anatomical plaque features obtained with CT based coronary angiography (CCTA).;Secondary Objective: Pharmacokinetics of the PET-tracers;Primary end point(s): This feasibility study will test different tracers for their feasibility to detect culprit lesions of patients with an ACS. Endpoints will be sufficient target to background uptake of tracer beyond 1.2 that coincides with the culprit lesion identified with OCT;Timepoint(s) of evaluation of this end point: On per patient basis evaluation will be reached within one week. On per study basis inclusion will be performed within one year, thereby endpoint will be reached.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacokinetics;Timepoint(s) of evaluation of this end point: Conform primary endpoint