Vulnerable Plaque Imaging in NSTEMI

Myocardial Infarction Clinical Trial

— CULPRIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02563964
• Other study ID #: NL51875.068.14 / METC 152007
• Status: Terminated
• Start date: September 1, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (12)

Ambrose JA, Winters SL, Stern A, Eng A, Teichholz LE, Gorlin R, Fuster V. Angiographic morphology and the pathogenesis of unstable angina pectoris. J Am Coll Cardiol. 1985 Mar;5(3):609-16. — View Citation

Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. Epub 2004 Aug 30. — View Citation

Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037. — View Citation

Glaser R, Selzer F, Faxon DP, Laskey WK, Cohen HA, Slater J, Detre KM, Wilensky RL. Clinical progression of incidental, asymptomatic lesions discovered during culprit vessel coronary intervention. Circulation. 2005 Jan 18;111(2):143-9. Epub 2004 Dec 27. — View Citation

Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11. — View Citation

Kato K, Yonetsu T, Kim SJ, Xing L, Lee H, McNulty I, Yeh RW, Sakhuja R, Zhang S, Uemura S, Yu B, Mizuno K, Jang IK. Nonculprit plaques in patients with acute coronary syndromes have more vulnerable features compared with those with non-acute coronary syndromes: a 3-vessel optical coherence tomography study. Circ Cardiovasc Imaging. 2012 Jul;5(4):433-40. doi: 10.1161/CIRCIMAGING.112.973701. Epub 2012 Jun 7. — View Citation

Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21. — View Citation

Kim RJ, Chen EL, Lima JA, Judd RM. Myocardial Gd-DTPA kinetics determine MRI contrast enhancement and reflect the extent and severity of myocardial injury after acute reperfused infarction. Circulation. 1996 Dec 15;94(12):3318-26. — View Citation

Kwee RM, van Oostenbrugge RJ, Mess WH, Prins MH, van der Geest RJ, ter Berg JW, Franke CL, Korten AG, Meems BJ, van Engelshoven JM, Wildberger JE, Kooi ME. MRI of carotid atherosclerosis to identify TIA and stroke patients who are at risk of a recurrence. J Magn Reson Imaging. 2013 May;37(5):1189-94. doi: 10.1002/jmri.23918. Epub 2012 Nov 16. — View Citation

Libby P, Theroux P. Pathophysiology of coronary artery disease. Circulation. 2005 Jun 28;111(25):3481-8. Review. — View Citation

Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358. Erratum in: N Engl J Med. 2011 Nov 24;365(21):2040. — View Citation

Virmani R, Kolodgie FD, Burke AP, Farb A, Schwartz SM. Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1262-75. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography.		0 to 6 months
Secondary	The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up.		0 to 6 months
Secondary	Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up.		0 to 6 months
Secondary	The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up.		0 to 6 months
Secondary	Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up.		0 to 6 months