Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol
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 aft...
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MDPI AG
2021-09-01
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| Series: | Medicina |
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| Online Access: | https://www.mdpi.com/1648-9144/57/10/1047 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Fabien Huet |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T06:25:03Z |
| format | Article |
| id | doaj.art-8941fe4d46ab4b5b992be83faeb575ea |
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| issn | 1010-660X 1648-9144 |
| language | English |
| last_indexed | 2024-03-10T06:25:03Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Medicina |
| spelling | doaj.art-8941fe4d46ab4b5b992be83faeb575ea2023-11-22T19:04:01ZengMDPI AGMedicina1010-660X1648-91442021-09-015710104710.3390/medicina57101047Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial ProtocolFabien Huet0Quentin Delbaere1Sylvain Aguilhon2Valentin Dupasquier3Delphine Delseny4Richard Gervasoni5Jean-Christophe Macia6Florence Leclercq7Nidal Jammoul8Sandra Kahlouche9Sonia Soltani10Fanny Cardon11Anne-Marie Dupuy12Jean-Paul Cristol13Denis Mariano-Goulart14Myriam Akodad15Nicolas Nagot16François Roubille17Department of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceBiostatistics and Research Unit, CHU Montpellier, Montpellier University Hospital, 34295 Montpelier, FranceDepartment of Biochemistry, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Biochemistry, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Nuclear Medicine, Montpellier University Hospital, 34295 Montpellier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceBiostatistics and Research Unit, CHU Montpellier, Montpellier University Hospital, 34295 Montpelier, FranceDepartment of Cardiology, Montpellier University Hospital, 34295 Montpellier, FranceInflammatory 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.https://www.mdpi.com/1648-9144/57/10/1047colchicinesympathetic innervationmyocardial infarctionheart rate variabilitynuclear imaging |
| spellingShingle | 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 Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol Medicina colchicine sympathetic innervation myocardial infarction heart rate variability nuclear imaging |
| title | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
| title_full | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
| title_fullStr | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
| title_full_unstemmed | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
| title_short | Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol |
| title_sort | colchicine to prevent sympathetic denervation after an acute myocardial infarction the cold mi trial protocol |
| topic | colchicine sympathetic innervation myocardial infarction heart rate variability nuclear imaging |
| url | https://www.mdpi.com/1648-9144/57/10/1047 |
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