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Vulnerable Plaque Imaging in NSTEMI (CULPRIT)

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ClinicalTrials.gov Identifier: NCT02563964
Recruitment Status : Terminated (Logistical reasons and slow recruitment)
First Posted : September 30, 2015
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date September 25, 2015
First Posted Date September 30, 2015
Last Update Posted Date March 12, 2020
Actual Study Start Date September 1, 2017
Actual Primary Completion Date March 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2015)
  • 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). [ Time Frame: 0 to 6 months ]
  • The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography. [ Time Frame: 0 to 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2015)
  • The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up. [ Time Frame: 0 to 6 months ]
  • Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up. [ Time Frame: 0 to 6 months ]
  • The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up. [ Time Frame: 0 to 6 months ]
  • Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up. [ Time Frame: 0 to 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vulnerable Plaque Imaging in NSTEMI
Official Title Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction Using 18F-NaF Positron Emission Tomography - Cardiac Magnetic Resonance Imaging: A Feasibility Study
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:

  1. Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive coronary angiography,
  2. Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with myocardial infarction using CMR, both at baseline and during follow-up,
  3. 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
  4. Examine the relation between vulnerable plaques and plasma biomarkers.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples Without DNA
Description:
Biomarkers
Sampling Method Probability Sample
Study Population Thirty-three patients, 18-85 years old and admitted with non-ST elevation myocardial infarction (NSTEMI). After informed consent, patients wil receive standard, guideline-based clinical care that includes invasive coronary angiography. Plasma biomaker will be sampled serially, and a comprehensive Sodium 18F-Fluoride Positron Emission Tomography/Cardiac Magnetic Resonance imaging (18F-NaF PET/CMR) will be performed at baseline (<72 hours) and at 6 months, or earlier when patients suffer recurrent myocardial infarction < 6months. Patients will be followed for one year during regular outpatient clinic visits.
Condition
  • Myocardial Infarction
  • Myocardial Ischemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 10, 2020)
10
Original Estimated Enrollment
 (submitted: September 28, 2015)
33
Actual Study Completion Date March 10, 2020
Actual Primary Completion Date March 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02563964
Other Study ID Numbers NL51875.068.14 / METC 152007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Joachim Wildberger, MD, PhD Maastricht University Medical Center
Principal Investigator: Harry J. Crijns, MD, PhD Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date March 2020