CULPRIT: Vulnerable Plaque Imaging in NSTEMI

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02563964

Collaborator

(none)

Enrollment

Location

30.3

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be related to insufficient vulnerable plaque identification using invasive coronary angiography. Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time and their relation with biomarkers need further exploration. More accurate identification and assessing long-term behaviour of vulnerable plaques may improve therapeutic strategies and clinical outcome. The investigators hypothesize that fully integrated 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging (PET/CMR) increases the ability to detect vulnerable plaques as compared to coronary angiography.

This prospective study in 33 consecutive patients with NSTEMI aims to:

Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive coronary angiography,
Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with myocardial infarction using CMR, both at baseline and during follow-up,
Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial disease), and
Examine the relation between vulnerable plaques and plasma biomarkers.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Myocardial Ischemia

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction Using 18F-NaF Positron Emission Tomography - Cardiac Magnetic Resonance Imaging: A Feasibility Study

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Mar 10, 2020

Actual Study Completion Date :

Mar 10, 2020

Outcome Measures

Primary Outcome Measures

The frequency of coronary vulnerable plaques in non-ST-elevation myocardial infarction (NSTEMI) using 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance (PET/CMR). [0 to 6 months]
The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography. [0 to 6 months]

Secondary Outcome Measures

The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up. [0 to 6 months]
Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up. [0 to 6 months]
The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up. [0 to 6 months]
Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up. [0 to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department <24 hours after symptom onset
Elevated levels of high-sensitivity troponin T (>14ng/L; initial blood sample at presentation or a second sample 3 hours after presentation)
Only patients scheduled for invasive coronary angiography
Age 18 years - 85 years
Mentally competent
Informed written consent

Exclusion Criteria:

Conservatively managed patients who are not scheduled for invasive coronary angiography
Refractory angina or on-going severe ischemia requiring immediate invasive coronary angiography
Patients requiring invasive coronary angiography < 24 hours after admission
Hemodynamic instability and cardiogenic shock (mean arterial pressure < 60 mmHg)
Severe heart failure (Killip Class ≥ III)
ST elevation myocardial infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block)
Chest pain highly suggestive of non-cardiac origin (as judged by the cardiac emergency department physician/cardiologist):
(Suspicion of) acute aortic dissection, acute pulmonary embolism, acute peri-myocarditis
Life threatening arrhythmias on the cardiac emergency department or prior to presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sino-artial or atrio-ventricular block)
Atrial fibrillation with ventricular rate ≥100 beats per minute (bpm)
Tachycardia (≥100/bpm)
Angina pectoris secondary to anaemia (<5.6 mmol/L), untreated hyperthyroidism, or severe hypertension (>200/110 mmHg)
More than mild aortic and mitral valve calcification or stenosis by latest echocardiography
Pregnancy
Breast feeding women
Life expectancy <2 years (malignancy, etc.)
Refusal of data storage until 15 years after end of study
Participation in another investigational study that has not reached its primary endpoint
Contraindications to cardiac magnetic resonance imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6202 AZ

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: Joachim Wildberger, MD, PhD, Maastricht University Medical Center
Principal Investigator: Harry J. Crijns, MD, PhD, Maastricht University Medical Center