Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04681612
Status:
UNKNOWN
Last Update Posted:
2020-12-29
First Post:
2020-12-13
Brief Title:
The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in MINOCA
Sponsor:
Hippocration General Hospital
Organization:
Hippocration General Hospital
Study Overview
Official Title:
The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISMA
Brief Summary:
Myocardial infarction with non-obstructive coronary arteries MINOCA occurs in 1-13 of all patients with acute myocardial infarction AMI According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones but face a significant risk for recurrent events of angina It has been demonstrated that sympathetic nervous system SNS overdrive during the acute phase of an acute coronary syndrome ACS has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms In the setting of MINOCA however data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach
The aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients In the same context this study is the first to the investigators knowledge registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance CMR imaging
This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 38-85 years old who fulfill the diagnostic criteria of MINOCA Patients will receive treatment according to the latest guidelines and consensus documents Assessment of SNS will include calculation of indices of heart rate and blood pressure variability as well as the measurement of muscle sympathetic nerve activity MSNA during the first 14 days following the event Follow-up will include a phone contact at 3 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints Definition of primary endpoints includes hospitalization for new onset of ACS heart failure stroke or transient ischemic attack cardiovascular death or death from any cause Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording recurrent angina assessed via Seattle Angina Questionnaire SAQ and the general health condition and quality of life QoL assessed using SF-12 questionnaire
The results of this study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms
The aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients In the same context this study is the first to the investigators knowledge registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance CMR imaging
This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 38-85 years old who fulfill the diagnostic criteria of MINOCA Patients will receive treatment according to the latest guidelines and consensus documents Assessment of SNS will include calculation of indices of heart rate and blood pressure variability as well as the measurement of muscle sympathetic nerve activity MSNA during the first 14 days following the event Follow-up will include a phone contact at 3 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints Definition of primary endpoints includes hospitalization for new onset of ACS heart failure stroke or transient ischemic attack cardiovascular death or death from any cause Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording recurrent angina assessed via Seattle Angina Questionnaire SAQ and the general health condition and quality of life QoL assessed using SF-12 questionnaire
The results of this study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms
Detailed Description:
BACKGROUND
Myocardial infarction with non-obstructive coronary arteries MINOCA occurs in 1-13 of all patients with acute myocardial infarction AMI According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones but face a significant risk for recurrent events of angina MINOCA consists a clinical entity characterized by a heterogeneous and poorly understood pathophysiological substrate plaque disruption coronary epicardial and microvascular spasm thromboembolism thrombophilia spontaneous dissection myocardial bridges microvascular dysfunction whereas current data leave significant knowledge gaps regarding the risk stratification and the proper therapeutical approach of these patients Sympathetic nervous system SNS overdrive during the acute phase of an acute coronary syndrome ACS is an expected reflex mechanism aiming to maintain homeostasis On the other hand it has been demonstrated that it has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms In the setting of MINOCA however data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach
AIM OF THE STUDY
The primary aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients Furthermore investigators will assess relations between various SNS parameters and clinical characteristics of these patients as well as other indices of cardiovascular function biomarkers imaging In the same context this study is the first to the investigators knowledge registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance CMR imaging
METHODS
This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 35-85 years old who fulfill the diagnostic criteria of MINOCA on the condition that CMR does not reveal findings compatible with a diagnosis of myocarditis or Takotsubo Patients will receive treatment according to the latest guidelines and consensus documents During hospitalization a complete medical history will be recorded and all basic clinical and lab parameters will be collected Assessment of SNS will include calculation of indices of heart rate and blood pressure variability derived from 24hr monitoring using validated devices as well as the measurement of muscle sympathetic nerve activity MSNA during the first 14 days following the event Follow-up will include a phone contact at 3 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints Definition of primary endpoints includes hospitalization for new onset of ACS heart failure stroke or transient ischemic attack cardiovascular death or death from any cause Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording recurrent angina assessed via Seattle Angina Questionnaire SAQ and the general health condition and quality of life QoL assessed using SF-12 questionnaire and Hospital Anxiety and Depression Scale HADS
- Sympathetic tone estimation
Α MSNA After patients stabilization the test will be performed and the derived data will be the number of bursts per min and the average bursts per 100 beats
B Ambulatory heart rate and blood pressure monitoring Heart rate variability will be analyzed via Kubios software for short-term and long-term heart rate variability Blood pressure short-term variability will be expressed as SD wSD ARV CV time rate of BP variation
For data analysis SPSS 240 software will be used Continuous parametric data will be expressed as mean and SD For categoric parametric data results will be presented in means of frequency and percentage Comparisons between categoric parameters will be done with test x2 Comparisons between the mean values for continuous parameters with normal distribution will be done via unpaired students test Comparisons between categoric parameters will be done with Mann Whitney U test Normal distribution will be checked with Kolmogorov-Smirnov test Correlation analysis will be done via Pearson Phi coefficient or Spearman Rho Statistically significant will be differences with p value 005 Evaluation of correlations between selected variables and cardiovascular events and mortality will be via Kaplan Maier curves
STUDY LIMITATIONS
Study will include MINOCA patients irrespective of the underlying pathophysiological mechanism This is the result of the inablity of most centers to perform intravascular imaging IVUS OCT on a routine basis and the tendency to avoid spasm provoking procedures during coronary angiography
Although most data will be recorded during the acutehospitalization phase the time frame of MSNA and CMR is expected to vary according to the clinical state of the participants and the technical capabilities of the centers However an effort will be made not to overlap the 14 days time limit proposed by the majority of investigators
CMR will be take place in different centers thus some extent of interobserver variability is expected However results will be reassessed by a single investigator
ESTIMATED RESEARCH OUTCOMES
It will be the first registry to the investigators knowledge that will record data of SNS activation in patients will CMR-confirmed MINOCA
The results of the present study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms
Furthermore assessment of correlations between parameters of cardiac function and CMR imaging with the level of SNS activation will provide a valuable insight towards the elucidation of the potential role of SNS overdrive during the acute phase of MINOCA
Last but not least follow up assessment will provide information regarding the long-term incidence of persistent or recurrent angina as well as the impact of MINOCA in future quality of life sentimental state and general health status
Myocardial infarction with non-obstructive coronary arteries MINOCA occurs in 1-13 of all patients with acute myocardial infarction AMI According to most studies MINOCA patients seem to have a more favorable prognosis compared to the obstructive AMI ones but face a significant risk for recurrent events of angina MINOCA consists a clinical entity characterized by a heterogeneous and poorly understood pathophysiological substrate plaque disruption coronary epicardial and microvascular spasm thromboembolism thrombophilia spontaneous dissection myocardial bridges microvascular dysfunction whereas current data leave significant knowledge gaps regarding the risk stratification and the proper therapeutical approach of these patients Sympathetic nervous system SNS overdrive during the acute phase of an acute coronary syndrome ACS is an expected reflex mechanism aiming to maintain homeostasis On the other hand it has been demonstrated that it has a deleterious impact on cardiovascular morbidity and mortality and this is the reason why contemporary treatment strategy of ACS aims towards the inhibition of SNS mechanisms In the setting of MINOCA however data are scarce regarding the prognostic role of SNS activation and the concomitant utility of a similar therapeutical approach
AIM OF THE STUDY
The primary aim of this study is to investigate the potential role of SNS in cardiovascular prognosis of MINOCA patients Furthermore investigators will assess relations between various SNS parameters and clinical characteristics of these patients as well as other indices of cardiovascular function biomarkers imaging In the same context this study is the first to the investigators knowledge registry where the working diagnosis of MINOCA will be confirmed with cardiac magnetic resonance CMR imaging
METHODS
This is an observational cohort study with a prospective follow-up of 18 months enrolling all patients aged 35-85 years old who fulfill the diagnostic criteria of MINOCA on the condition that CMR does not reveal findings compatible with a diagnosis of myocarditis or Takotsubo Patients will receive treatment according to the latest guidelines and consensus documents During hospitalization a complete medical history will be recorded and all basic clinical and lab parameters will be collected Assessment of SNS will include calculation of indices of heart rate and blood pressure variability derived from 24hr monitoring using validated devices as well as the measurement of muscle sympathetic nerve activity MSNA during the first 14 days following the event Follow-up will include a phone contact at 3 6 and 12 months to record potential primary endpoints and a clinic visit at 18 months to reassess clinical and lab parameters and record primary and secondary endpoints Definition of primary endpoints includes hospitalization for new onset of ACS heart failure stroke or transient ischemic attack cardiovascular death or death from any cause Secondary endpoints include the burden of arrythmias estimated from 24hr ECG recording recurrent angina assessed via Seattle Angina Questionnaire SAQ and the general health condition and quality of life QoL assessed using SF-12 questionnaire and Hospital Anxiety and Depression Scale HADS
- Sympathetic tone estimation
Α MSNA After patients stabilization the test will be performed and the derived data will be the number of bursts per min and the average bursts per 100 beats
B Ambulatory heart rate and blood pressure monitoring Heart rate variability will be analyzed via Kubios software for short-term and long-term heart rate variability Blood pressure short-term variability will be expressed as SD wSD ARV CV time rate of BP variation
For data analysis SPSS 240 software will be used Continuous parametric data will be expressed as mean and SD For categoric parametric data results will be presented in means of frequency and percentage Comparisons between categoric parameters will be done with test x2 Comparisons between the mean values for continuous parameters with normal distribution will be done via unpaired students test Comparisons between categoric parameters will be done with Mann Whitney U test Normal distribution will be checked with Kolmogorov-Smirnov test Correlation analysis will be done via Pearson Phi coefficient or Spearman Rho Statistically significant will be differences with p value 005 Evaluation of correlations between selected variables and cardiovascular events and mortality will be via Kaplan Maier curves
STUDY LIMITATIONS
Study will include MINOCA patients irrespective of the underlying pathophysiological mechanism This is the result of the inablity of most centers to perform intravascular imaging IVUS OCT on a routine basis and the tendency to avoid spasm provoking procedures during coronary angiography
Although most data will be recorded during the acutehospitalization phase the time frame of MSNA and CMR is expected to vary according to the clinical state of the participants and the technical capabilities of the centers However an effort will be made not to overlap the 14 days time limit proposed by the majority of investigators
CMR will be take place in different centers thus some extent of interobserver variability is expected However results will be reassessed by a single investigator
ESTIMATED RESEARCH OUTCOMES
It will be the first registry to the investigators knowledge that will record data of SNS activation in patients will CMR-confirmed MINOCA
The results of the present study are expected to reveal the prognostic role of SNS assessment in patients with MINOCA with a potential clinical implication in a treatment approach towards the inhibition of SNS mechanisms
Furthermore assessment of correlations between parameters of cardiac function and CMR imaging with the level of SNS activation will provide a valuable insight towards the elucidation of the potential role of SNS overdrive during the acute phase of MINOCA
Last but not least follow up assessment will provide information regarding the long-term incidence of persistent or recurrent angina as well as the impact of MINOCA in future quality of life sentimental state and general health status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None