An observational study in Myocardial Infarction With Nonobstructive Coronary Arteries, sponsored by Hippocration General Hospital. Status unknown at 1 site in Greece. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Hippocration General Hospital · Observational
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.
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).
Α. MSNA. After patient's 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 24.0 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 student's 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 \< 0.05. Evaluation of correlations between selected variables and cardiovascular events and mortality will be via Kaplan Maier curves.
STUDY LIMITATIONS
ESTIMATED RESEARCH OUTCOMES
29 studies on the registry are indexed under MINOCA; 18 are open to participants now.
This study's planned enrollment of 150 is below the median of 500 across 20 observational studies indexed under MINOCA.
Browse MINOCA studies →Hippocration General Hospital is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients hospitalized with MINOCA according to working group position paper and after CMR confirmation of ischemic pattern LGE (excluding myocarditis and Takotsubo)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients hospitalised with MINOCA according to the recently published consensus document of ESC after cardiac MRI confirmation.
Diagnostic Test: MSNA · Diagnostic Test: Heart Rate Variability · Diagnostic Test: Blood Pressure Variability · Diagnostic Test: CMR · Diagnostic Test: History, Lab, clinical and hemodynamic parameters
Assessed via Muscle Microneurography during the first 14 days of the acute phase. Indices: busts/min, busts/100bpm
Assessed via 24hr ECG monitoring during the first 14 days of the acute phase. Indices: Time-domain, Frequency-domain, Non-linear
Assessed via Ambulatory BPM during the first 14 days of the acute phase. Indices: SD, wSD, ARV, CV
Cardiac Magnetic Resonance during the first 14 days of the acute phase. Assessment of oedema, Late Gadolinium Enhancement ischaemic pattern. Assessment of cardiac function parameters
1. Description of event, 2. Risk factors, 3. Medical history, 4. ECG parameters, 5. ECHO parameters, 6. Hemodynamic parameters of acute phase and hospitalization, 7. Coronary angiogram paraemeters, 7. Complete lab parameter assessment, 8. Thrombofilia assessment, 9. SF-12 QoL and Anxiety and Depression Scale (HADS) questionnaires
Incidence (%) of Death during follow up
Number of participants dead due to cardiovascular or any other cause
Time frame: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Incidence (%) of Hospitalization for Major Cardiovascular Events (MACEs) during follow up
Number of participants hospitalized due to: ACS (STEMI,NSTEMI,Unstable Angina), Decompensated heart failure, Stroke
Time frame: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Incidence (%) of the Composite endpoint
Incidence (%) of the composite endpoint that includes: Number of participants either hospitalized for MaCEs (ACS, Decompensated heart failure, Stroke) or dead due to a cardiovascular or any other cause
Time frame: Assessed at 4 time points after the acute event: 3 months, 6 months, 12 months, 18 months
Frequency (%) of increased long term arrythmia burden
Number of participants fulfilling 1 or more criteria for increased arrythmia burden assessed via 24hr ECG monitor at follow up visit. Criteria assessed: PVCs\>10%, AF\>30sec, NSVT, complete heart block
Time frame: Assessed at 18 months after the acute event
Frequency of long term Sustained/ Reccurent Angina
Seattle angina questionnaire (SAQ) will be filled by participants at follow up visit. SAQ provides a quantification of sentimental and physical impact of angina on participants. It is a 19-question self-administered questionnaire assessing physical limitation, angina persistence and frequency, satisfaction of treatment and the overall impact of the disease on the participant. Scores range from 0 to 100. Lower scores depict a greater overall impact of angina on the participant.
Time frame: Assessed at 18 months after the acute event
Assessment of Quality of Life and General Health Status
Medical Outcomes Study 12-Item Short Form (SF-12) will be filled by participants during the acute phase and follow up visit in order to assess the long term impact of MINOCA on the participants' quality of life. SF-12 consists of 12 questions and its score ranges from 0 to 100. Lower scores depict a worse quality of life for the participant.
Time frame: Assessed at 1-14 days and 18 months after the acute event
Assessment of Sentimental status
Hospital Anxiety and Depresion Scale (HADS) questionnaire will be filled by participants during the acute phase and follow up visit in order to assess the long term impact of MINOCA on the participants' emotional status (anxiety, depression). HADS consists of 14 questions and its score ranges from 0 to 21 separetely for anxiety and depression quantification. Scores: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case), 11-21 = Abnormal (case).
Time frame: Assessed at 1-14 days and 18 months after the acute event
Plan to share: No
Started Oct 2019 (actual). Primary completion is estimated for Apr 2023, 42 months after the start.
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Hippocration General Hospital