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NCT04681612: PRISMA
The Prognostic Role of Indices of Sympathetic Nervous System Overdrive in MINOCA
trial testing MSNA in Myocardial Infarction With Nonobstructive Coronary Arteries in 150 participants. Status unknown.
30 April 2023
Quick facts
| Lead sponsor | Hippocration General Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 8 October 2019 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 October 2023 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- MSNA
- Heart Rate Variability
- Blood Pressure Variability
- CMR
- History, Lab, clinical and hemodynamic parameters
Conditions studied
- Myocardial Infarction With Nonobstructive Coronary Arteries — all drugs for Myocardial Infarction With Nonobstructive Coronary Arteries →
Sponsor
Hippocration General Hospital
Who can join
Adults 35 to 85, any sex, with Myocardial Infarction With Nonobstructive Coronary Arteries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04681612
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04681612 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hippocration General Hospital
- Last refreshed: 29 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04681612.
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