Proteomic Profiling of Coronary Thrombus in Acute Myocardial Infarction

NCT03731884 | Unknown

• 1 other identifier: PROTEOTHR18
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

ST-elevation myocardial infarction (STEMI) is mostly caused by the rupture or the erosion of a vulnerable atherosclerotic plaque, initiating with intraluminal thrombosis and resulting in total occlusion of the coronary artery. Thrombus formation is a complex and dynamic process involving flow, blood cells and several plasma proteins, and it has not been clearly elucidated. To define - through proteomic approach - the composition of occluding thrombus and its time changes in patients with STEMI, trying to identify novel biomarkers of coronary thrombosis.

Conditions

Acute Myocardial Infarction; STEMI - ST Elevation Myocardial Infarction

Keywords

Coronary thrombus; Proteomics; Lipidomics; Thrombus aspiration

Outcome Measures

Primary Outcomes (1)

• Change through time in thrombus proteomic composition

  Compare concentrations of different protein types in the supernatant of thrombus from patients with STEMI\<3hs vs \<3hs, through proteomic approaches

  within 24 hours

Study Arms (2)

Elapsed time of onset-of-pain-to-PCI <3 hours

Patients with AMI undergoing percutaneous coronary intervention (PCI) prior to 3 hours from the onset of symptoms

Other: Time from the onset of symptoms to PCI

Elapsed time of onset-of-pain-to-PCI >3 hours

Patients with AMI undergoing percutaneous coronary intervention (PCI) after at least 3 hours from the onset of symptoms

Other: Time from the onset of symptoms to PCI

Interventions

Time from the onset of symptoms to PCI OTHER

Patients will be divided in two groups according to the time from the onset of symptoms to PCI

Elapsed time of onset-of-pain-to-PCI <3 hours; Elapsed time of onset-of-pain-to-PCI >3 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A consecutive series of patients admitted for an ACS, with either STEMI and occluded infarct-related artery or NSTEMI and visible thrombus in the culprit artery will be deemed suitable for thrombus aspiration. PCI will be performed with a standard procedure, with either femoral or radial access.

You may qualify if:

• patients with STEMI and occluded infarct-related artery or NSTEMI and visible thrombus deemed suitable for thrombus aspiration

You may not qualify if:

• thrombus aspiration not performed or unsuccessfull

Sponsors & Collaborators

• G. d'Annunzio University: lead
• Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Santissima Annunziata Hospital

Chieti, Italy

RECRUITING

Related Publications (3)

• Pieragostino D, D'Alessandro M, di Ioia M, Rossi C, Zucchelli M, Urbani A, Di Ilio C, Lugaresi A, Sacchetta P, Del Boccio P. An integrated metabolomics approach for the research of new cerebrospinal fluid biomarkers of multiple sclerosis. Mol Biosyst. 2015 Jun;11(6):1563-72. doi: 10.1039/c4mb00700j.

  PMID: 25690641 BACKGROUND

• Del Boccio P, Pieragostino D, Di Ioia M, Petrucci F, Lugaresi A, De Luca G, Gambi D, Onofrj M, Di Ilio C, Sacchetta P, Urbani A. Lipidomic investigations for the characterization of circulating serum lipids in multiple sclerosis. J Proteomics. 2011 Nov 18;74(12):2826-36. doi: 10.1016/j.jprot.2011.06.023. Epub 2011 Jul 4.

  PMID: 21757039 BACKGROUND

• Zimarino M, Angeramo F, Prasad A, Ruggieri B, Malatesta S, Prati F, Buttitta F, De Caterina R. Reduction of atherothrombotic burden before stent deployment in non-ST elevation acute coronary syndromes: Reduction of myocardial necrosis achieved with nose-dive manual thrombus aspiration (REMNANT) trial. A volumetric intravascular ultrasound study. Catheter Cardiovasc Interv. 2016 Nov;88(5):716-725. doi: 10.1002/ccd.26301. Epub 2015 Nov 3.

  PMID: 26527239 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lyophilized thrombus extracted by thrombus-aspiration in patients with acute myocardial infarction

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Marco Zimarino, MD, PhD

  G. D'Annunzio University. Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Damiana Pieragostino

  Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University - Chieti

  STUDY CHAIR

Central Study Contacts

Marco Zimarino, MD, PhD

CONTACT

+39 3476045261; m.zimarino@unich.it

Francesco Radico, MD

CONTACT

+39 3474943605; francescoradico@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 6, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)