ST Elevation Myocardial Infarction (STEMI) Patients Clinical Trial
— SHOCk-NICaSOfficial title:
ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study
| NCT number | NCT04586764 |
| Other study ID # | HS22904 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 9, 2019 |
| Est. completion date | October 31, 2024 |
Proposed novel solution for high-risk heart disease Overall in-hospital mortality among ST
elevation myocardial infarction (STEMI) patients is 3-4%, but >50% patients experiencing
cardiogenic shock (CS) secondary to STEMI die in the hospital. Evidence suggests early
diagnosis and treatment of CS results in improved outcomes, albeit, there is no tool to
diagnose CS reliably in a timely fashion in STEMI patients through the continuous monitoring.
We hypothesize that bioimpedance-derived hemodynamic measures obtained using the Non-Invasive
Cardiac System (NICaS) can facilitate early detection of CS, predict outcomes, and
revolutionize the STEMI patient management. The objectives of SHOCk-NICaS study in STEMI
patients are to: a) identify the CS early, using NICaS derived cardiac index of ≤1.8L/min/m2
or ≤2.2L/min/m2 with the use of vasopressor and/or inotropes, and compare it with the
incidence of CS based upon lactate level ≥2mmol/L, and systolic blood pressure <90mmHg; b):
determine the impact of primary percutaneous coronary intervention (PPCI), using NICaS
derived hemodynamic measures (stroke volume, cardiac index, cardiac power index, etc), by
comparing pre- and post-angioplasty; and c) identify outcome-associated hemodynamic markers.
A composite score of death during hospital stay, prolonged hospitalization due to heart
failure (>72hrs), and use of inotropic or mechanical circulation support is a primary
outcome.
Methodology This is a multi-center, double-blind, prospective cohort study enrolling STEMI
patients aged ≥18years visiting at 4 cardiac centers (St Boniface, St. Michael's, McGill
University Hospital). Using validated NICaS protocol, hemodynamic parameters will be recorded
at baseline, during the PPCI procedure, and within 24-hour post PPCI without altering the
standard care. Statistical analysis: Baseline data will be reported as mean±SD or
median±interquartile range. The outcomes will be assessed using multivariable logistic
regression. We will analyze the impact of age, sex, gender, and ethnicity on hemodynamic
measures. The targeted 500 patients will ensure a margin of error of 5% at a 95% CI. So far
recruited 76 STEMI patients mark the study feasibility.
Significance This novel study in high-risk STEMI patients will provide a promising
cost-effective, rapid, and non-invasive tool to identify CS early; a prompt intervention may
curtail the high morbidity and mortality. The meticulously designed pragmatic study outcomes
may revolutionize STEMI patient management.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 31, 2024 |
| Est. primary completion date | October 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients aged =18 years, presenting with EKG confirmed diagnosis of STEMI - Able to understand, and consent to participate in the study Exclusion Criteria: - Patients unwilling to participate in the study - Patients with any life-threatening medical condition with an expected life span of =1 year (e.g., metastatic cancer, terminal COPD) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | St. Boniface Hospital | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | Scripps Health, Sharp HealthCare, University of British Columbia, University of Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prolonged hospitalization due to heart failure (> 96 hours) | Documented pulmonary edema on x-ray chest, elevated BNP or initiation of diuretic therapy lasting longer than 24 hours. | At 7 days | |
| Primary | Use of inotropic - vasopressor therapy | Use of norepinephrine, epinephrine, milrinone, dobutamine, or dopamine | At 7 days | |
| Primary | Use of mechanical circulation support | Intra aortic balloon pump, impella or extra-corporeal membrane oxygenation (ECMO) insertion | At 7 days | |
| Primary | Death | At 7 days | ||
| Primary | Death | At 30 days | ||
| Primary | Death | At 1 year | ||
| Secondary | Killip classification | Killip class I - No signs of congestion Killip class II - Presence of S3 on clinical examination and/or basal rales on auscultation Class III - Acute pulmonary edema Class IV - Cardiogenic shock or hypotension (systolic blood pressure < 90 mmHg) and evidence of peripheral vasoconstriction characterized by oliguria, cold extremities or sweating. | At 24 hours | |
| Secondary | New-onset atrial/ventricular arrhythmia | Documented evidence of atrial - ventricular arrhythmia. Atrial fibrillation Atrial flutter Non-sustained ventricular tachycardia Sustained ventricular tachycardia Ventricular fibrillation |
At 30 days | |
| Secondary | New-onset atrial/ventricular arrhythmia | Documented evidence of atrial - ventricular arrhythmia. Atrial fibrillation Atrial flutter Non-sustained ventricular tachycardia Sustained ventricular tachycardia Ventricular fibrillation |
From 30 days to 1 year | |
| Secondary | New diagnosis of heart failure | Documented pulmonary edema on x-ray chest, elevated BNP or initiation of diuretic therapy lasting longer than 24 hours. | At 30 days | |
| Secondary | New diagnosis of heart failure | Documented pulmonary edema on x-ray chest, elevated BNP or initiation of diuretic therapy lasting longer than 24 hours. | From 30 days to 1 year | |
| Secondary | Implantable Cardioverter Defibrillator (ICD) implantation | At 1 year | ||
| Secondary | Cardiac Re-synchronization Therapy/Defibrillator (CRT-D) implantation | At 1 year |