Myocardial Infarction Clinical Trial
Official title:
Acute and Chronic Protective Effects of Peri-interventional Administration of Levosimendan in ST Elevation Myocardial Infarctions
NCT number | NCT03022877 |
Other study ID # | Levo-STEMI |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2017 |
Est. completion date | December 2018 |
Verified date | October 2022 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - STEMI of the anterior wall < 6 hrs - capacity to Consent Exclusion Criteria: - previous myocardial infarction or bypass surgery - relevant vitium - STEMI of the posterior wall - any contraindications to MRI - unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure - onset of symptoms more than 6 hours. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Brooks GC, Lee BK, Rao R, Lin F, Morin DP, Zweibel SL, Buxton AE, Pletcher MJ, Vittinghoff E, Olgin JE; PREDICTS Investigators. Predicting Persistent Left Ventricular Dysfunction Following Myocardial Infarction: The PREDICTS Study. J Am Coll Cardiol. 2016 Mar 15;67(10):1186-1196. doi: 10.1016/j.jacc.2015.12.042. — View Citation
du Toit EF, Smith W, Muller C, Strijdom H, Stouthammer B, Woodiwiss AJ, Norton GR, Lochner A. Myocardial susceptibility to ischemic-reperfusion injury in a prediabetic model of dietary-induced obesity. Am J Physiol Heart Circ Physiol. 2008 May;294(5):H233 — View Citation
Hein M, Roehl AB, Baumert JH, Scherer K, Steendijk P, Rossaint R. Anti-ischemic effects of inotropic agents in experimental right ventricular infarction. Acta Anaesthesiol Scand. 2009 Aug;53(7):941-8. doi: 10.1111/j.1399-6576.2009.01994.x. Epub 2009 May 6 — View Citation
Kin H, Zhao ZQ, Sun HY, Wang NP, Corvera JS, Halkos ME, Kerendi F, Guyton RA, Vinten-Johansen J. Postconditioning attenuates myocardial ischemia-reperfusion injury by inhibiting events in the early minutes of reperfusion. Cardiovasc Res. 2004 Apr 1;62(1): — View Citation
Kloner RA, Jennings RB. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: part 2. Circulation. 2001 Dec 18;104(25):3158-67. Review. — View Citation
Qarawani D, Cohen A, Nahir M, Hasin Y. Facilitation of left ventricular function recovery post percutaneous coronary intervention by levosimendan. Int J Cardiol. 2013 Sep 20;168(1):237-42. doi: 10.1016/j.ijcard.2012.09.088. Epub 2012 Oct 11. — View Citation
Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi) | echocardiography and MRI examinations (LVEDVi) and comparison between baseline and 12 months data | 12 months after coronary intervention due to the infarction | |
Secondary | Size of the acute myocardial damage due to the infarction | MRI examination (infarction area) and comparison between baseline and 12 months data | 12 months after coronary intervention due to the infarction | |
Secondary | Event-free survival | collection of data from the patient after 12 months about adverse events as myocardial infarction, stroke, revascularization and death | 12 months after coronary intervention due to the infarction | |
Secondary | functional changes (imaging) | echocardiography and MRI examinations about LV function | 12 months after coronary intervention due to the infarction | |
Secondary | structural changes | MRI examinations about fibrosis | 12 months after coronary intervention due to the infarction | |
Secondary | functional changes (spirometry) | changes of capacity by spirometry. | 12 months after coronary intervention due to the infarction |
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