The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in MINOCA

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.

Conditions

• Myocardial Infarction With Nonobstructive Coronary Arteries

Interventions

DIAGNOSTIC_TEST

MSNA

Assessed via Muscle Microneurography during the first 14 days of the acute phase. Indices: busts/min, busts/100bpm

DIAGNOSTIC_TEST

Heart Rate Variability

Assessed via 24hr ECG monitoring during the first 14 days of the acute phase. Indices: Time-domain, Frequency-domain, Non-linear

DIAGNOSTIC_TEST

Blood Pressure Variability

Assessed via Ambulatory BPM during the first 14 days of the acute phase. Indices: SD, wSD, ARV, CV

DIAGNOSTIC_TEST

CMR

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

DIAGNOSTIC_TEST

History, Lab, clinical and hemodynamic 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

Sponsors & Collaborators

• 401 General Military Hospital of Athens

  collaborator OTHER

• 251 Hellenic Air Force & VA General Hospital

  collaborator OTHER

• Athens Naval Hospital

  collaborator UNKNOWN

• Evangelismos General Hospital

  collaborator UNKNOWN

• Aleksandra General Hospital

  collaborator UNKNOWN

• Sismanoglio General Hospital

  collaborator OTHER

• G.Gennimatas General Hospital

  collaborator OTHER

• Tzaneio General Hospital of Pireus

  collaborator UNKNOWN

• Elpis General Hospital

  collaborator UNKNOWN

• Thriasio General Hospital of Elefsina

  collaborator OTHER

• Laiko General Hospital

  collaborator UNKNOWN

• Attikon Hospital

  collaborator OTHER

• KAT General Hospital

  collaborator OTHER

• Hippocration General Hospital

  lead OTHER

Principal Investigators

• Emmanouil K. Mantzouranis, MD · Hippokration Hospital

• Ioannis E. Leontsinis, MD · Hippokration Hospital

Eligibility

Min Age

35 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-08

Primary Completion

2023-04-30

Completion

2023-10-30

Countries

• Greece

Study Locations