Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement

NCT ID: NCT03047681

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2017-12-01

Brief Summary

An association between mast cells and outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) has not been studied to our knowledge. We aim to characterize tryptase levels dynamics during TAVR; Demonstrate whether tryptase level post-TAVR can be used as a prognostic marker.

Detailed Description

Inflammation is known to have a detrimental effect on outcome of patients with myocardial infarction (MI) [1, 2] as well as reperfusion injury (RI) [3]. Previous trials have shown correlation between the extent of an inflammatory response and postoperative complications and worse outcomes in patients undergoing cardiac surgery [4, 5, 6, 7] including valve replacement [8]. Transcatheter aortic valve replacement (TAVR) may be associated with inflammation [5, 9] as well. A few possible mechanisms may be responsible, such as tissue injury due to mechanical trauma, vascular complications, and possible suboptimal organ perfusion due to bleeding, ventricular pacing, balloon valvuloplasty, deployment, post-dilatation, or repositioning of the valve prosthesis [10]. Accumulating data show that peri-procedural inflammation is associated with worse outcomes and complications of TAVR [11, 12, 13, 14, 15], and may predict increased mortality in patients after TAVR [16, 17, 18, 19, 20].

Inflammation is a complex process and includes many types of cells including mast cells. The association between mast cells, as part of the inflammatory process, and RI has been thoroughly studied. Mast cells have been linked to RI in many organs [21], contributing to insult to the myocardium. This association has been suggested from animal models [22, 23, 24] as well as recent human trials which showed that tryptase, an abundant protease found in mast cell granules, is elevated in ST segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI) [25].

Therefore, it is reasonable to assume that mast cells may have a role in the inflammation process involved in patients undergoing TAVR. Moreover, such association with mast cells may be used to predict adverse outcomes.

To our knowledge, an association between mast cells and outcomes of patients undergoing TAVR has not been studied.

METHODS Peripheral venous blood from 30 patients undergoing TAVR will be withdrawn to examine tryptase levels, as a marker of mast cell activity. Blood samples will be taken at 0 hours (before the procedure) and a second sample will be taken up to 2 hours post-procedure.

CRP will be examined in each patient pre and post TAVR. Tryptase levels will be examined in 10 patients undergoing diagnostic coronary angiography.

PRIMARY OBJECTIVE We aim to: 1. Characterize tryptase levels dynamics during TAVR 2. Demonstrate whether tryptase level post-TAVR can be used as a prognostic marker.

Primary outcome - mortality at 1 year Secondary outcomes - Major complications at 7 days and 30 days, including death, major stroke, acute kidney injury, paravalvular regurgitation, permanent pacemaker implantation, coronary artery obstruction, heart block, vascular injury, pericardial hemorrhage.

REFERENCES:

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Conditions

Transcatheter Aortic Valve Implantation Prosnosis and Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

patients undergoin transcatheter aortic valve implantation

venous blood withdrawl

Intervention Type: DIAGNOSTIC_TEST

patients will be asked for a venous blood sample

Control group

patient undergoing diagnostic coronary angiography

venous blood withdrawl

Intervention Type: DIAGNOSTIC_TEST

patients will be asked for a venous blood sample

Interventions

venous blood withdrawl

patients will be asked for a venous blood sample

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 18 years of age and older
• Capable of giving informed consent
• Undergoing TAVR

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Zach Rozenbaum, MD

Role: primary

zachr@tlvmc.gov.il

972-3-6973313

Other Identifiers

0678-15-TLV

Identifier Type: -

Identifier Source: org_study_id