ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study (SHOCk-NICaS)

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.

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction (STEMI) Patients
• Intervention / Treatment: Device: Non-Invasive Cardiac System

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Ashish H Shah, MD, MD-Res (UK),MRCP; Phone Number: 204-237-2315; Email: ashah5@sbgh.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
      • St. Boniface Hospital
      • Contact: Ashish H Shah, MD; Phone Number: 204-237-2315; Email: ashah5@sbgh.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with STEMI

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		At 1 year
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
Use of inotropic - vasopressor therapy	Use of norepinephrine, epinephrine, milrinone, dobutamine, or dopamine	At 7 days
Use of mechanical circulation support	Intra aortic balloon pump, impella or extra-corporeal membrane oxygenation (ECMO) insertion	At 7 days
Death		At 7 days
Death		At 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Implantable Cardioverter Defibrillator (ICD) implantation		At 1 year
Cardiac Re-synchronization Therapy/Defibrillator (CRT-D) implantation		At 1 year

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: University of British Columbia; University of Toronto; Scripps Health; Sharp HealthCare

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2019
• Primary Completion (ANTICIPATED): October 31, 2023
• Study Completion (ANTICIPATED): October 31, 2024

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: HS22904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No