Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol
| Title: | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
|---|---|
| Authors: | Fabien Huet, Quentin Delbaere, Sylvain Aguilhon, Valentin Dupasquier, Delphine Delseny, Richard Gervasoni, Jean-Christophe Macia, Florence Leclercq, Nidal Jammoul, Sandra Kahlouche, Sonia Soltani, Fanny Cardon, Anne-Marie Dupuy, Jean-Paul Cristol, Denis Mariano-Goulart, Myriam Akodad, Nicolas Nagot, François Roubille |
| Source: | Medicina, Vol 57, Iss 10, p 1047 (2021) |
| Publisher Information: | MDPI AG, 2021. |
| Publication Year: | 2021 |
| Collection: | LCC:Medicine (General) |
| Subject Terms: | colchicine, sympathetic innervation, myocardial infarction, heart rate variability, nuclear imaging, Medicine (General), R5-920 |
| More Details: | Inflammatory processes are deeply involved in ischemia-reperfusion injuries (IRI) and ventricular remodelling (VR) after a ST-segment elevation myocardial infarction (STEMI). They are associated with clinical adverse events (heart failure and cardiovascular death) adding damage to the myocardium after reperfusion. Moreover, acute myocardial infarction (AMI) induces a local sympathetic denervation leading to electrical instability and arrythmia. Colchicine, a well-known alkaloid with direct anti-inflammatory effects, was shown to reduce the myocardial necrosis size and limit the VR. In a recent proof of concept study, colchicine appears to prevent sympathetic denervation in a mice model of ischemia/reperfusion, but not in the necrosis or in the border zone areas. The Colchicine to Prevent Sympathetic Denervation after an AMI study (COLD-MI) is an ongoing, confirmative, prospective, monocentre, randomized, open-label trial. The COLD-MI trial aims to evaluate the intensity of sympathetic denervation after AMI and its potential modulation due to low dose colchicine. Sympathetic denervation will be noninvasively evaluated using single-photon emission computed tomography (SPECT). After a first episode of STEMI (Initial TIMI flow ≤ 1) and primary percutaneous coronary intervention (PPCI), patients will be randomized (n = 56) in a 1:1 ratio to either receive colchicine or not for 30 days. The primary end point will be the percentage of myocardial denervation measured by 123I-metaiodobenzylguanidine (123I-MIBG) SPECT at a 6-month follow-up. The main secondary end points will be basic ECG parameters (QRS duration, corrected QT) and HRV parameters from a 24 hour-recording Holter at 1- and 6-months follow-up. Results from this study will contribute to a better understanding of the cardioprotective effect of colchicine after AMI. The present study describes the rationale, design, and methods of the trial. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1648-9144 1010-660X |
| Relation: | https://www.mdpi.com/1648-9144/57/10/1047; https://doaj.org/toc/1010-660X; https://doaj.org/toc/1648-9144 |
| DOI: | 10.3390/medicina57101047 |
| Access URL: | https://doaj.org/article/8941fe4d46ab4b5b992be83faeb575ea |
| Accession Number: | edsdoj.8941fe4d46ab4b5b992be83faeb575ea |
| Database: | Directory of Open Access Journals |
| ISSN: | 16489144 1010660X |
|---|---|
| DOI: | 10.3390/medicina57101047 |
| Published in: | Medicina |
| Language: | English |