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

NCT04586764 | Unknown DMC

• 1 other identifier: HS22904
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

• Death

  At 1 year

Secondary Outcomes (7)

• Killip classification

  At 24 hours

• New-onset atrial/ventricular arrhythmia

  At 30 days

• New-onset atrial/ventricular arrhythmia

  From 30 days to 1 year

• New diagnosis of heart failure

  At 30 days

• New diagnosis of heart failure

  From 30 days to 1 year

Interventions

Non-Invasive Cardiac System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with STEMI

You may qualify if:

• Patients aged ≥18 years, presenting with EKG confirmed diagnosis of STEMI
• Able to understand, and consent to participate in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead
• University of Toronto: collaborator
• University of British Columbia: collaborator
• Scripps Health: collaborator
• Sharp HealthCare: collaborator

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

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

CONTACT

204-237-2315; ashah5@sbgh.mb.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 14, 2020
• Study Start: October 9, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2024
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CA (1)