Safety and Tolerability of Sodium Thiosulfate in Patients with an Acute Coronary Syndrome Undergoing Coronary Angiography: A Dose-Escalation Safety Pilot Study (SAFE-ACS): A Dose-Escalation Safety Pilot Study (SAFE-ACS)
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| Název: | Safety and Tolerability of Sodium Thiosulfate in Patients with an Acute Coronary Syndrome Undergoing Coronary Angiography: A Dose-Escalation Safety Pilot Study (SAFE-ACS): A Dose-Escalation Safety Pilot Study (SAFE-ACS) |
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| Autoři: | Marie-Sophie Louise Yvonne de Koning, Erik Lipsic, Harry van Goor, Dirk J. van Veldhuisen, Pim van der Harst, Andreas Pasch, Carlijn G. Maagdenberg, Solmaz Assa |
| Přispěvatelé: | Team Medisch, Circulatory Health |
| Zdroj: | J Interv Cardiol Journal of Interventional Cardiology, Vol 2020 (2020) |
| Informace o vydavateli: | Wiley, 2020. |
| Rok vydání: | 2020 |
| Témata: | Adult, Male, INDUCED HEARING-LOSS, Thiosulfates, ISCHEMIA-REPERFUSION INJURY, Myocardial Reperfusion Injury, Pilot Projects, HYDROGEN-SULFIDE, Coronary Angiography, Protective Agents, DISEASE, CARDIOPROTECTION, 03 medical and health sciences, Thiosulfates/administration & dosage, 0302 clinical medicine, Myocardial Reperfusion Injury/etiology, Journal Article, Diseases of the circulatory (Cardiovascular) system, Humans, Acute Coronary Syndrome, Dose-Response Relationship, Drug, CALCIFIC UREMIC ARTERIOLOPATHY, Protective Agents/administration & dosage, Middle Aged, Acute Coronary Syndrome/diagnosis, 3. Good health, Coronary Angiography/adverse effects, TRIALS, MYOCARDIAL-INFARCTION, RC666-701, Female, Research Article |
| Popis: | Background. In animal studies, hydrogen sulfide (H2S) has been shown to protect the heart from ischemia-reperfusion injury. This study evaluates the safety and tolerability of the H2S donor sodium thiosulfate (STS) in patients with acute coronary syndrome (ACS).Methods. Eighteen patients, undergoing coronary angiography for ACS, received STS intravenously immediately after arrival at the catheterization laboratory according to a “3 + 3 dose-escalation design” with fixed dosing endpoint (0, 2.5, 5, 10, 12.5, and 15 grams). This first dose STS was combined with verapamil and nitroglycerin required for transradial procedures. A second dose STS was administered 6 hours later. Primary endpoint was dose-limiting toxicity, defined as significant hemodynamic instability or death up to 24 hours or before discharge from the coronary care unit. Secondary outcomes included the occurrence of anaphylaxis, nausea, vomiting, and systolic blood pressure (SBP) course.Results. Sixteen patients received two dosages of STS and two patients one dosage. None of the patients reached the primary endpoint, nor experienced a serious adverse event. We observed a clinically well-tolerated decline in SBP 1 hour after administration of the first STS dose and concomitant verapamil/nitroglycerin. SBP for all patients together reduced 16.8 (8.1–25.5) mmHg (P=0.0008). No significant decline in SBP occurred after the second dose. Mild nausea was observed in one patient.Conclusion. This is the first report on sodium thiosulfate administration in patients with acute coronary syndromes. Our data suggest that sodium thiosulfate was well tolerated in this setting. The potential benefit of this intervention has to be examined in larger studies. |
| Druh dokumentu: | Article Other literature type |
| Popis souboru: | text/xhtml; application/pdf |
| Jazyk: | English |
| ISSN: | 1540-8183 0896-4327 |
| DOI: | 10.1155/2020/6014915 |
| Přístupová URL adresa: | https://downloads.hindawi.com/journals/jitc/2020/6014915.pdf https://pubmed.ncbi.nlm.nih.gov/33041696 https://doaj.org/article/dd14a2044e7341c4a968501aca0f7901 https://www.hindawi.com/journals/jitc/2020/6014915/ https://www.ncbi.nlm.nih.gov/pubmed/33041696 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532357 https://downloads.hindawi.com/journals/jitc/2020/6014915.pdf http://downloads.hindawi.com/journals/jitc/2020/6014915.pdf https://research.rug.nl/en/publications/safety-and-tolerability-of-sodium-thiosulfate-in-patients-with-an https://dspace.library.uu.nl/handle/1874/445489 |
| Rights: | CC BY |
| Přístupové číslo: | edsair.doi.dedup.....cb7e18a7ba8df8468f9bb4bfaede3cc9 |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Background. In animal studies, hydrogen sulfide (H2S) has been shown to protect the heart from ischemia-reperfusion injury. This study evaluates the safety and tolerability of the H2S donor sodium thiosulfate (STS) in patients with acute coronary syndrome (ACS).Methods. Eighteen patients, undergoing coronary angiography for ACS, received STS intravenously immediately after arrival at the catheterization laboratory according to a “3 + 3 dose-escalation design” with fixed dosing endpoint (0, 2.5, 5, 10, 12.5, and 15 grams). This first dose STS was combined with verapamil and nitroglycerin required for transradial procedures. A second dose STS was administered 6 hours later. Primary endpoint was dose-limiting toxicity, defined as significant hemodynamic instability or death up to 24 hours or before discharge from the coronary care unit. Secondary outcomes included the occurrence of anaphylaxis, nausea, vomiting, and systolic blood pressure (SBP) course.Results. Sixteen patients received two dosages of STS and two patients one dosage. None of the patients reached the primary endpoint, nor experienced a serious adverse event. We observed a clinically well-tolerated decline in SBP 1 hour after administration of the first STS dose and concomitant verapamil/nitroglycerin. SBP for all patients together reduced 16.8 (8.1–25.5) mmHg (P=0.0008). No significant decline in SBP occurred after the second dose. Mild nausea was observed in one patient.Conclusion. This is the first report on sodium thiosulfate administration in patients with acute coronary syndromes. Our data suggest that sodium thiosulfate was well tolerated in this setting. The potential benefit of this intervention has to be examined in larger studies. |
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| ISSN: | 15408183 08964327 |
| DOI: | 10.1155/2020/6014915 |