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Factors that influence the decision to accept or decline to participate in clinical research: A qualitative study
Topic 4 — Ischemia-reperfusion, acute coronary syndrome, stroke — C Objective The goal of this study was to decipher the impact of CypD deacetylation mediated by SIRT3 in PC in the aging context. Methods We submitted young (2 months) and old (≤ 12 months) mice, WT and SIRT3 KO, to IR and IPC. IS were quantified, and mitochondrial protein acetylation was evaluated. In parallel, basal mitochondrial functions and protein acetylation were assessed, as well as deacetylase activity, to estimate the impact of aging. Results Our results enlightened the importance of SIRT3 for PC success in young mice (25% IS reduction), that is lost in the old mice. We reported no more modification of the acetylation profile neither after IR or IPC in old mice. Moreover, we quantified a significant decrease in deacetylase activity with age (25%), associated to a significant decrease in NAD+ content (60%) with no basal mitochondrial function modification in old mice that could be associated to the loss of IPC efficiency. Conclusion In accordance with what we demonstrated in young mice, the failure of IPC in old mice could be explained by a lack of CypD deacetylation following IPC stimulus, linked with an alteration of the deacetylase mitochondrial activity associated to a significant decrease in NAD+ mitochondrial content. Disclosure of interest The authors declare that they have no competing interest. https://doi.org/10.1016/j.acvdsp.2018.02.026 050
Factors that influence the decision to accept or decline to participate in clinical research: A qualitative study F. Ecarnot ∗ , R. Chopard , F. Schiele , N. Meneveau Cardiologie, CHU de Besanc¸on, Besanc¸on, France ∗ Corresponding author. E-mail address: fi[email protected] (F. Ecarnot) Introduction Guidelines rely on evidence-based data, and clinical research is key to providing this evidence-base. Yet the factors that influence decisions to participate in research remain poorly documented. Objective We investigated factors that determine the decision to accept or decline clinical trial participation in a qualitative study. Methods Single-centre, qualitative study using semi-directive interviews with patients (pts) who had been invited to participate in a randomized clinical trial and who had given their decision. Pts who refused and accepted were included. There were no inclusion criteria; all pts who met the inclusion criteria of the selected trial and had been approached for consent were eligible. Verbatim from the interviews were analysed using a grounded theory approach. Results 11 patients have been interviewed; average age 75 ± 7 years. One patient did not know if he was currently participating in a trial; 1 said he was not participating although he had provided consent. The main themes that arose were: (1) the positive value of the trial for the patient, although some pts clearly do not understand the concept of randomization; (2) the level of engagement in the process of care (some pts do not bother to read the information given to them, but just accept what is proposed without question, while others decline immediately without reading trial information). Two dimensions emerge, namely physical and emotional health, with a spectrum ranging from fragile to robust. Where the patient is situated on this spectrum appears to influence their attitude towards research participation.
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Conclusions The decision to participate (or not) in clinical research appears to be more related to the patient’s general behaviour and attitude when sick, rather than any specific trialrelated constraints or advantages. The level of comprehension of pts who have been through the consent process casts a doubt on the ‘‘informed’’ character of the consent. Disclosure of interest The authors declare that they have no competing interest. https://doi.org/10.1016/j.acvdsp.2018.02.027 193
Circadian variations of infarct size and inflammation response in patients presenting a STEMI T. Bochaton 1,2,∗ , H. Bernelin 1 , A. Paccalet 2 , C. Crola Da Silva 2 , D. Baetz 2 , E. Bonnefoy-Cudraz 1 , N. Mewton 3 , M. Ovize 2,4 1 Plateau urgences et soins intensifs, hôpital cardiologique Louis-Pradel, Lyon, France 2 INSERM U1060, CarMeN laboratory, IHU OPeRa, Bron, France 3 Centre d’investigation clinique, hospices civils de Lyon, France 4 Service d’explorations fonctionnelles cardiovasculaires, hôpital cardiologique Louis-Pradel, Lyon, France ∗ Corresponding author. E-mail address: [email protected] (T. Bochaton) Introduction Circadian rhythm modulates many physiological functions. Some studies suggest a circadian variation of infarct size (IS) in experimental models and in human. It is also known that inflammation is modulated according to circadian rhythm. Inflammation has a central role in post-MI remodeling and final IS. Circadian variation of IS and inflammation response after MI are unknown. Objective Our objective was to evaluate the modulation of IS according to the reperfusion time of the day and to assess if post-MI inflammation was also modulated by circadian rhythm. Method In our biobank, we selected 115 patients who presented with a ST-elevated Myocardial Infarction (STEMI). Two groups were done according to the reperfusion time of day. The morning group (MG) was reperfused between 6:01 am and 12:00 and the afternoon group (AG) was reperfused between 12:01 and 6:00 pm. Each patient had a blood sample upon admission and 4 hours after reperfusion. IS was assessed using cardiac magnetic resonance (MRI) imaging. Main inflammatory markers as interleukin (IL)-6, IL-8, IL-10 and Creactive protein (CRP) were dosed using ELISA. Results There were 53 patients in the MG and 62 patients in the AG. Patients characteristics were similar in the two groups, especially ischemia time (median of 165 min in both groups). We observed that IS assessed by MRI was significantly reduced by 23.2% in the AG compared to the MG (P = 0.04). Furthermore, patients reperfused the afternoon showed a less intense inflammation reaction post-MI with a 54% decrease of CRP (P = 0.004) and 30% decrease of IL-6 (P = 0.047) compared to the MG. IL-8 and IL-10 levels were similar in the 2 groups. Conclusion We confirmed a circadian variation of myocardial IS in STEMI reperfused patients according to the reperfusion time of the day. The largest IS was observed in the MG. CRP and IL-6 were also modulated according to circadian rhythm with a higher level the morning compared to the afternoon. Disclosure of interest The authors declare that they have no competing interest. https://doi.org/10.1016/j.acvdsp.2018.02.028
Factors that influence the decision to accept or decline to participate in clinical research: A qualitative study F. Ecarnot ∗ , R. Chopard , F. Schiele , N. Meneveau Cardiologie, CHU de Besanc¸on, Besanc¸on, France ∗ Corresponding author. E-mail address: fi[email protected] (F. Ecarnot) Introduction Guidelines rely on evidence-based data, and clinical research is key to providing this evidence-base. Yet the factors that influence decisions to participate in research remain poorly documented. Objective We investigated factors that determine the decision to accept or decline clinical trial participation in a qualitative study. Methods Single-centre, qualitative study using semi-directive interviews with patients (pts) who had been invited to participate in a randomized clinical trial and who had given their decision. Pts who refused and accepted were included. There were no inclusion criteria; all pts who met the inclusion criteria of the selected trial and had been approached for consent were eligible. Verbatim from the interviews were analysed using a grounded theory approach. Results 11 patients have been interviewed; average age 75 ± 7 years. One patient did not know if he was currently participating in a trial; 1 said he was not participating although he had provided consent. The main themes that arose were: (1) the positive value of the trial for the patient, although some pts clearly do not understand the concept of randomization; (2) the level of engagement in the process of care (some pts do not bother to read the information given to them, but just accept what is proposed without question, while others decline immediately without reading trial information). Two dimensions emerge, namely physical and emotional health, with a spectrum ranging from fragile to robust. Where the patient is situated on this spectrum appears to influence their attitude towards research participation.
187
Conclusions The decision to participate (or not) in clinical research appears to be more related to the patient’s general behaviour and attitude when sick, rather than any specific trialrelated constraints or advantages. The level of comprehension of pts who have been through the consent process casts a doubt on the ‘‘informed’’ character of the consent. Disclosure of interest The authors declare that they have no competing interest. https://doi.org/10.1016/j.acvdsp.2018.02.027 193
Circadian variations of infarct size and inflammation response in patients presenting a STEMI T. Bochaton 1,2,∗ , H. Bernelin 1 , A. Paccalet 2 , C. Crola Da Silva 2 , D. Baetz 2 , E. Bonnefoy-Cudraz 1 , N. Mewton 3 , M. Ovize 2,4 1 Plateau urgences et soins intensifs, hôpital cardiologique Louis-Pradel, Lyon, France 2 INSERM U1060, CarMeN laboratory, IHU OPeRa, Bron, France 3 Centre d’investigation clinique, hospices civils de Lyon, France 4 Service d’explorations fonctionnelles cardiovasculaires, hôpital cardiologique Louis-Pradel, Lyon, France ∗ Corresponding author. E-mail address: [email protected] (T. Bochaton) Introduction Circadian rhythm modulates many physiological functions. Some studies suggest a circadian variation of infarct size (IS) in experimental models and in human. It is also known that inflammation is modulated according to circadian rhythm. Inflammation has a central role in post-MI remodeling and final IS. Circadian variation of IS and inflammation response after MI are unknown. Objective Our objective was to evaluate the modulation of IS according to the reperfusion time of the day and to assess if post-MI inflammation was also modulated by circadian rhythm. Method In our biobank, we selected 115 patients who presented with a ST-elevated Myocardial Infarction (STEMI). Two groups were done according to the reperfusion time of day. The morning group (MG) was reperfused between 6:01 am and 12:00 and the afternoon group (AG) was reperfused between 12:01 and 6:00 pm. Each patient had a blood sample upon admission and 4 hours after reperfusion. IS was assessed using cardiac magnetic resonance (MRI) imaging. Main inflammatory markers as interleukin (IL)-6, IL-8, IL-10 and Creactive protein (CRP) were dosed using ELISA. Results There were 53 patients in the MG and 62 patients in the AG. Patients characteristics were similar in the two groups, especially ischemia time (median of 165 min in both groups). We observed that IS assessed by MRI was significantly reduced by 23.2% in the AG compared to the MG (P = 0.04). Furthermore, patients reperfused the afternoon showed a less intense inflammation reaction post-MI with a 54% decrease of CRP (P = 0.004) and 30% decrease of IL-6 (P = 0.047) compared to the MG. IL-8 and IL-10 levels were similar in the 2 groups. Conclusion We confirmed a circadian variation of myocardial IS in STEMI reperfused patients according to the reperfusion time of the day. The largest IS was observed in the MG. CRP and IL-6 were also modulated according to circadian rhythm with a higher level the morning compared to the afternoon. Disclosure of interest The authors declare that they have no competing interest. https://doi.org/10.1016/j.acvdsp.2018.02.028