PET-CT and its RElationship in detection of Coronary plaques with Intravascular imaging methods: Optical coherence tomography (OCT) and intravascular UltraSound (IVUS)

PET-CT and its RElationship in detection of Coronary plaques with Intravascular imaging methods: Optical coherence tomography (OCT) and intravascular UltraSound (IVUS) - PRECIOUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36003

Enrollment

Registered

2011-10-25

Start date

2012-06-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

instable plaque vulnerable plaque

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Consecutive patients with symptoms of acute coronary syndromes without ST-segment elevation are eligible for this study if the following three inclusion criteria apply: a. One or more episodes of anginal symptoms at rest or at minimal exertion within the last 5 days, presumed to be ischemic in origin and lasting at least 5 minutes b. Troponin or CKMB concentration above the upper reference limit c. An indication for percutaneous coronary intervention (PCI) of a de novo culprit lesion with at least one non-culprit vessel with a 40mm proximal segment without stenoses of more 50%, suitable for IVUS and OCT

Exclusion criteria

Exclusion criteria: a. Persistent ST-segment elevation of >1mm in two or more contiguous electrocardiographic leads b. Impaired renal function (eGFR 50% stenosis. q. Significant, diffuse 3-vessel coronary artery disease, requiring treatment. r. Known tendency to coronary vasospasm. s. Not possible to perform 18F-FDG PET-CT within 72 hours after PCI. t. Persistent irregular heart rhythm

Design outcomes

Primary

Measure	Time frame
1. Correlation between Target-to-Background Ratios (TBRs) and necrotic core in contact with lumen (NCCL) / Plaque Burden (PB) measured with IVUS. 2. Correlation between TBRs and fibrous, fibrolipidic, necrotic core, or calcium content of plaques found with IVUS in every ROI. 3. Correlation between TBRs and macrophage quantification / cap thickness on OCT in every ROI. 4. Correlation in median and max TBR between coronary arteries and the other investigated arteries.	—

Measure

Time frame

1. Correlation between Target-to-Background Ratios (TBRs) and necrotic core in contact with lumen (NCCL) / Plaque Burden (PB) measured with IVUS. 2. Correlation between TBRs and fibrous, fibrolipidic, necrotic core, or calcium content of plaques found with IVUS in every ROI. 3. Correlation between TBRs and macrophage quantification / cap thickness on OCT in every ROI. 4. Correlation in median and max TBR between coronary arteries and the other investigated arteries.

—

Secondary

Measure	Time frame
1. Correlation between biomarkers and macrophage quantification/ cap thickness on OCT. 2. Correlation between biomarkers and max TBR on PET-CT. 3. Correlation between NCCL, PB, plaque content found with IVUS-VH and cap thickness found on OCT.	—

Countries

Netherlands

Outcome results