Transcatheter Aortic Valve Implantation Prosnosis and ComplicationsTAVRNCT03047681
Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement
An observational study of Transcatheter Aortic Valve Implantation Prosnosis and Complications, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcatheter Aortic Valve Implantation Prosnosis and Complications
- What is being tested?
- venous blood withdrawl
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who undergo TAVR
Who may be able to join
- 18 years of age and older
- Capable of giving informed consent
- Undergoing TAVR
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Zach Rozenbaum, MD, 972-3-6973313, zachr@tlvmc.gov.il
Zach Rozenbaum, MD
About this study
Official title: Tryptase Levels as a Marker of Mast Cell Activity and the Prognostic Implication in Patients Post Transcatheter Aortic Valve Replacement
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.
Read the 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:
- Patel MR, Mahaffey KW, Armstrong PW, Weaver WD, Tasissa G, Hochman JS, Todaro TG, Malloy KJ, Rollins S, Theroux P, Ruzyllo W, Nicolau JC, Granger CB. Prognostic usefulness of white blood cell count and temperature in acute myocardial infarction (from the CARDINAL Trial). Am J Cardiol 2005;95:614-618.
- Theroux P, Armstrong PW, Mahaffey KW, Hochman JS, Malloy KJ, Rollins S, Nicolau JC, Lavoie J, Luong TM, Burchenal J, Granger CB. Prognostic significance of blood markers of inflammation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty and effects of pexelizumab, a C5 inhibitor: a substudy of the COMMA trial. Eur Heart J 2005;26:1964-1970.
- Ibáñez B, Heusch G, Ovize M, Van de Werf F. Evolving therapies for myocardial ischemia/reperfusion injury. J Am Coll Cardiol. 2015 Apr 14;65(14):1454-71.
- Cremer J, Martin M, Redl H, Bahrami S, Abraham C, Graeter T, Haverich A, Schlag G, Borst HG. Systemic inflammatory response syndrome after cardiac operations. Ann Thorac Surg 1996;61:1714-1720.
- Lindman BR, Goldstein JS, Nassif ME, Zajarias A, Novak E, Tibrewala A, Vatterott AM, Lawler C, Damiano RJ, Moon MR, Lawton JS, Lasala JM, Maniar HS. Systemic inflammatory response syndrome after transcatheter or surgical aortic valve replacement. Heart 2015 Apr;101(7):537-45.
- Kilger E, Heyn J, Beiras-Fernandez A, et al. Stress doses of hydrocortisone reduce systemic inflammatory response in patients undergoing cardiac surgery without cardiopulmonary bypass. Minerva Anestesiol. 2011;77:268-274.
- Clarizia NA, Manlhiot C, Schwartz SM, et al. Improved outcomes associated with intraoperative steroid use in high-risk pediatric cardiac surgery. Ann Thorac Surg. 2011;91(4):1222-1227.
- Prat C, Ricart P, Ruyra X, et al. Serum concentrations of procalcitonin after cardiac surgery. J Card Surg. 2008;23(6):627-632.
- Stähli BE1, Grünenfelder J, Jacobs S, Falk V, Landmesser U, Wischnewsky MB, Lüscher TF, Corti R, Maier W, Altwegg LA. Assessment of inflammatory response to transfemoral transcatheter aortic valve implantation compared to transapical and surgical procedures: a pilot study. J Invasive Cardiol. 2012 Aug;24(8):407-11.
- Sinning JM1, Scheer AC, Adenauer V, Ghanem A, Hammerstingl C, Schueler R, Müller C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Systemic inflammatory response syndrome predicts increased mortality in patients after transcatheter aortic valve implantation. Eur Heart J. 2012 Jun;33(12):1459-68.
- Masson JB1, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20.
- Toggweiler S1, Webb JG. Challenges in transcatheter aortic valve implantation. Swiss Med Wkly. 2012 Dec 17;142:w13735.
- Rettig TC1, Rigter S1, Nijenhuis VJ2, van Kuijk JP2, ten Berg JM2, Heijmen RH3, van de Garde EM4, Noordzij PG. The systemic inflammatory response syndrome predicts short-term outcome after transapical transcatheter aortic valve implantation. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):283-7.
- Krumsdorf U1, Chorianopoulos E, Pleger ST, Kallenbach K, Karck M, Katus HA, Bekeredjian R. C-reactive protein kinetics and its prognostic value after transfemoral aortic valve implantation. J Invasive Cardiol. 2012 Jun;24(6):282-6.
- Van Linden A1, Kempfert J, Rastan AJ, Holzhey D, Blumenstein J, Schuler G, Mohr FW, Walther T. Risk of acute kidney injury after minimally invasive transapical aortic valve implantation in 270 patients. Eur J Cardiothorac Surg. 2011 Jun;39(6):835-42; discussion 842-3.
- Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, Hambrecht R, Sack S, Hauptmann KE, Richardt G, Figulla HR, Senges J. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 2011;32:198-204
- Sinning JM, Ghanem A, Steinhauser H, Adenauer V, Hammerstingl C, Nickenig G, Werner N. Renal function as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation. JACC Cardiovasc Interv 2010;3:1141-1149.
- Nuis RJ, van Mieghem NM, Tzikas A, Piazza N, Otten AA, Cheng J, van Domburg RT, Betjes M, Serruys PW, de Jaegere PP. Frequency, determinants and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2011;77:881-889.
- Aregger F, Wenaweser P, Hellige GJ, Kadner A, Carrel T, Windecker S, Frey FJ. Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement. Nephrol Dial Transplant 2009;24:2175-2179.
- Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, Masson JB, Gutierrez MJ, Clavel MA, Bertrand OF, Pibarot P, Rodes-Cabau J. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J 2010;31:865-874. Van Linden A, Kempfert J, Rastan AJ, Holzhey D, Blumenstein J, Schuler G, Mohr FW, Walther T. Risk of acute kidney injury after minimally invasive trans-apical aortic valve implantation in 270 patients. Eur J Cardiothorac Surg 2011;39:835-42.
- Yang MQ1, Ma YY, Ding J, Li JY. The role of mast cells in ischemia and reperfusion injury. Inflamm Res. 2014 Nov;63(11):899-905.
- Masini E, Giannella E, Bianchi S, Mannaioni PF: Histamine and lactate dehydrogenase (LDH) release in ischemic myocardium of the guinea-pig. Agents Actions 1987;20:281-283.
- Masini E1, Bianchi S, Gambassi F, Palmerani B, Pistelli A, Carlomagno L, Mannaioni PF. Ischemia reperfusion injury and histamine release in isolated and perfused guinea-pig heart: pharmacological interventions. Agents Actions. 1990 Apr;30(1-2):198-201
- Frangogiannis NG1, Perrard JL, Mendoza LH, Burns AR, Lindsey ML, Ballantyne CM, Michael LH, Smith CW, Entman ML. Stem cell factor induction is associated with mast cell accumulation after canine myocardial ischemia and reperfusion. Circulation. 1998 Aug 18;98(7):687-98.
- Shaomin Chen, Di Mu, Ming Cui, Chuan Ren, Shu Zhang, Lijun Guo, and Wei Gao. Dynamic changes and clinical significance of serum tryptase levels in STEMI patients treated with primary PCI. Biomarkers. 2014 Nov;19(7):620-4.
- Being tested
- venous blood withdrawl
- Keywords
- TAVR, tryptse, mast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous blood withdrawlDiagnostic test
patients will be asked for a venous blood sample
| Study group | Role | What they receive |
|---|---|---|
| Study group | patients undergoin transcatheter aortic valve implantation Receives: Diagnostic Test: venous blood withdrawl | |
| Control group | patient undergoing diagnostic coronary angiography Receives: Diagnostic Test: venous blood withdrawl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
mortality
Measured: 1 year
Secondary outcomes (2)
Mortality
mortality at 7 and 30 days
Measured: 7 and 30 days
Complications
Post procedural complications - major stroke, acute kidney injury, paravalvular regurgitation, permanent pacemaker implantation, coronary artery obstruction, heart block, vascular injury, pericardial hemorrhage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startFeb 2017 (estimated)
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Implantation Prosnosis and ComplicationsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047681
- Sponsor's protocol ID
- 0678-15-TLV
- Acronym
- TAVR
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the principle investigator will have access to IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tryptase Levels as a Marker of Mast Cell Activity and the Prognostic Implication in Patients Post Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03047681
- Acronym / sponsor ID
- TAVR / 0678-15-TLV
- Keywords
- TAVR, tryptse, mast
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2017 (estimated)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patel MR, Mahaffey KW, Armstrong PW, Weaver WD, Tasissa G, Hochman JS, Todaro TG, Malloy KJ, Rollins S, Theroux P, Ruzyllo W, Nicolau JC, Granger CB. Prognostic usefulness of white blood cell count and temperature in acute myocardial infarction (from the CARDINAL Trial). Am J Cardiol 2005;95:614-618.
- Theroux P, Armstrong PW, Mahaffey KW, Hochman JS, Malloy KJ, Rollins S, Nicolau JC, Lavoie J, Luong TM, Burchenal J, Granger CB. Prognostic significance of blood markers of inflammation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty and effects of pexelizumab, a C5 inhibitor: a substudy of the COMMA trial. Eur Heart J 2005;26:1964-1970.
- Ibáñez B, Heusch G, Ovize M, Van de Werf F. Evolving therapies for myocardial ischemia/reperfusion injury. J Am Coll Cardiol. 2015 Apr 14;65(14):1454-71.
- Cremer J, Martin M, Redl H, Bahrami S, Abraham C, Graeter T, Haverich A, Schlag G, Borst HG. Systemic inflammatory response syndrome after cardiac operations. Ann Thorac Surg 1996;61:1714-1720.
- Lindman BR, Goldstein JS, Nassif ME, Zajarias A, Novak E, Tibrewala A, Vatterott AM, Lawler C, Damiano RJ, Moon MR, Lawton JS, Lasala JM, Maniar HS. Systemic inflammatory response syndrome after transcatheter or surgical aortic valve replacement. Heart 2015 Apr;101(7):537-45.
- Kilger E, Heyn J, Beiras-Fernandez A, et al. Stress doses of hydrocortisone reduce systemic inflammatory response in patients undergoing cardiac surgery without cardiopulmonary bypass. Minerva Anestesiol. 2011;77:268-274.
- Clarizia NA, Manlhiot C, Schwartz SM, et al. Improved outcomes associated with intraoperative steroid use in high-risk pediatric cardiac surgery. Ann Thorac Surg. 2011;91(4):1222-1227.
- Prat C, Ricart P, Ruyra X, et al. Serum concentrations of procalcitonin after cardiac surgery. J Card Surg. 2008;23(6):627-632.
- Stähli BE1, Grünenfelder J, Jacobs S, Falk V, Landmesser U, Wischnewsky MB, Lüscher TF, Corti R, Maier W, Altwegg LA. Assessment of inflammatory response to transfemoral transcatheter aortic valve implantation compared to transapical and surgical procedures: a pilot study. J Invasive Cardiol. 2012 Aug;24(8):407-11.
- Sinning JM1, Scheer AC, Adenauer V, Ghanem A, Hammerstingl C, Schueler R, Müller C, Vasa-Nicotera M, Grube E, Nickenig G, Werner N. Systemic inflammatory response syndrome predicts increased mortality in patients after transcatheter aortic valve implantation. Eur Heart J. 2012 Jun;33(12):1459-68.
- Masson JB1, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20.
- Toggweiler S1, Webb JG. Challenges in transcatheter aortic valve implantation. Swiss Med Wkly. 2012 Dec 17;142:w13735.
- Rettig TC1, Rigter S1, Nijenhuis VJ2, van Kuijk JP2, ten Berg JM2, Heijmen RH3, van de Garde EM4, Noordzij PG. The systemic inflammatory response syndrome predicts short-term outcome after transapical transcatheter aortic valve implantation. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):283-7.
- Krumsdorf U1, Chorianopoulos E, Pleger ST, Kallenbach K, Karck M, Katus HA, Bekeredjian R. C-reactive protein kinetics and its prognostic value after transfemoral aortic valve implantation. J Invasive Cardiol. 2012 Jun;24(6):282-6.
- Van Linden A1, Kempfert J, Rastan AJ, Holzhey D, Blumenstein J, Schuler G, Mohr FW, Walther T. Risk of acute kidney injury after minimally invasive transapical aortic valve implantation in 270 patients. Eur J Cardiothorac Surg. 2011 Jun;39(6):835-42; discussion 842-3.
- Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, Hambrecht R, Sack S, Hauptmann KE, Richardt G, Figulla HR, Senges J. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 2011;32:198-204
- Sinning JM, Ghanem A, Steinhauser H, Adenauer V, Hammerstingl C, Nickenig G, Werner N. Renal function as predictor of mortality in patients after percutaneous transcatheter aortic valve implantation. JACC Cardiovasc Interv 2010;3:1141-1149.
- Nuis RJ, van Mieghem NM, Tzikas A, Piazza N, Otten AA, Cheng J, van Domburg RT, Betjes M, Serruys PW, de Jaegere PP. Frequency, determinants and prognostic effects of acute kidney injury and red blood cell transfusion in patients undergoing transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2011;77:881-889.
- Aregger F, Wenaweser P, Hellige GJ, Kadner A, Carrel T, Windecker S, Frey FJ. Risk of acute kidney injury in patients with severe aortic valve stenosis undergoing transcatheter valve replacement. Nephrol Dial Transplant 2009;24:2175-2179.
- Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, Masson JB, Gutierrez MJ, Clavel MA, Bertrand OF, Pibarot P, Rodes-Cabau J. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J 2010;31:865-874. Van Linden A, Kempfert J, Rastan AJ, Holzhey D, Blumenstein J, Schuler G, Mohr FW, Walther T. Risk of acute kidney injury after minimally invasive trans-apical aortic valve implantation in 270 patients. Eur J Cardiothorac Surg 2011;39:835-42.
- Yang MQ1, Ma YY, Ding J, Li JY. The role of mast cells in ischemia and reperfusion injury. Inflamm Res. 2014 Nov;63(11):899-905.
- Masini E, Giannella E, Bianchi S, Mannaioni PF: Histamine and lactate dehydrogenase (LDH) release in ischemic myocardium of the guinea-pig. Agents Actions 1987;20:281-283.
- Masini E1, Bianchi S, Gambassi F, Palmerani B, Pistelli A, Carlomagno L, Mannaioni PF. Ischemia reperfusion injury and histamine release in isolated and perfused guinea-pig heart: pharmacological interventions. Agents Actions. 1990 Apr;30(1-2):198-201
- Frangogiannis NG1, Perrard JL, Mendoza LH, Burns AR, Lindsey ML, Ballantyne CM, Michael LH, Smith CW, Entman ML. Stem cell factor induction is associated with mast cell accumulation after canine myocardial ischemia and reperfusion. Circulation. 1998 Aug 18;98(7):687-98.
- Shaomin Chen, Di Mu, Ming Cui, Chuan Ren, Shu Zhang, Lijun Guo, and Wei Gao. Dynamic changes and clinical significance of serum tryptase levels in STEMI patients treated with primary PCI. Biomarkers. 2014 Nov;19(7):620-4.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: venous blood withdrawlpatients undergoin transcatheter aortic valve implantation |
| Control group | – | Diagnostic Test: venous blood withdrawlpatient undergoing diagnostic coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who undergo TAVR
Key inclusion criteria (3 listed)
- 18 years of age and older
- Capable of giving informed consent
- Undergoing TAVR
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous blood withdrawlpatients will be asked for a venous blood sample | Diagnostic test | Control group, Study group |
Primary outcome
Mortality
Time frame: 1 year
mortality
2 secondary outcomes
Mortality
Time frame: 7 and 30 days
Complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No. Only the principle investigator will have access to IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation Prosnosis and Complications, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.