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

NCT ID: NCT04586764

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

ST Elevation Myocardial Infarction (STEMI) Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non-Invasive Cardiac System

Non-Invasive Cardiac System (NICaS, NI Medical, Israel) is a non-invasive hemodynamic monitoring system that records various cardiovascular parameters including stroke volume, cardiac output, cardiac index (CI), total peripheral vascular resistance, body water content, and cardiac power index, a marker of myocardial contractility by employing the principles of the whole body impedance cardiography.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Scripps Health

OTHER

Sponsor Role: collaborator

Sharp HealthCare

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Ashish H Shah

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ashish H Shah, MD, MD-Res (UK),MRCP

Role: CONTACT

ashah5@sbgh.mb.ca

204-237-2315

Facility Contacts

Ashish H Shah, MD

Role: primary

ashah5@sbgh.mb.ca

204-237-2315

Other Identifiers

HS22904

Identifier Type: -

Identifier Source: org_study_id