ST Elevation Myocardial Infarction (STEMI) PatientsSHOCk-NICaSNCT04586764
ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study
An observational study of ST Elevation Myocardial Infarction (STEMI) Patients, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction (STEMI) Patients
- What is being tested?
- Non-Invasive Cardiac System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 9 Oct 2019to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with STEMI
Who may be able to join
- Patients aged ≥18 years, presenting with EKG confirmed diagnosis of STEMI
- Able to understand, and consent to participate in the study
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Ashish H Shah, MD, 204-237-2315, ashah5@sbgh.mb.ca
About this study
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.
- Being tested
- Non-Invasive Cardiac System
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Cardiac SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 7 days
Use of inotropic - vasopressor therapy
Use of norepinephrine, epinephrine, milrinone, dobutamine, or dopamine
Measured: At 7 days
Use of mechanical circulation support
Intra aortic balloon pump, impella or extra-corporeal membrane oxygenation (ECMO) insertion
Measured: At 7 days
Death
Measured: At 7 days
Death
Measured: At 30 days
Death
Measured: At 1 year
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From 30 days to 1 year
Implantable Cardioverter Defibrillator (ICD) implantation
Measured: At 1 year
Cardiac Re-synchronization Therapy/Defibrillator (CRT-D) implantation
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start9 Oct 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial Infarction (STEMI) PatientsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of British Columbia, Scripps Health, Sharp HealthCare
- Responsible party
- Principal investigator, Ashish H Shah, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586764
- Sponsor's protocol ID
- HS22904
- Acronym
- SHOCk-NICaS
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ST Elevation Myocardial Infarction Hemodynamic OutComes: Role of Non-Invasive Cardiac System (SHOCk-NICaS) Study
- ClinicalTrials.gov ID
- NCT04586764
- Acronym / sponsor ID
- SHOCk-NICaS / HS22904
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Toronto, University of British Columbia, Scripps Health, Sharp HealthCare
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with STEMI
Key inclusion criteria (2 listed)
- Patients aged ≥18 years, presenting with EKG confirmed diagnosis of STEMI
- Able to understand, and consent to participate in the study
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Cardiac SystemNon-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. | Device | – |
Primary outcome
Prolonged hospitalization due to heart failure (> 96 hours)
Time frame: At 7 days
Documented pulmonary edema on x-ray chest, elevated BNP or initiation of diuretic therapy lasting longer than 24 hours.
Use of inotropic - vasopressor therapy
Time frame: At 7 days
Use of norepinephrine, epinephrine, milrinone, dobutamine, or dopamine
Use of mechanical circulation support
Time frame: At 7 days
Intra aortic balloon pump, impella or extra-corporeal membrane oxygenation (ECMO) insertion
Death
Time frame: At 7 days
Death
Time frame: At 30 days
Death
Time frame: At 1 year
7 secondary outcomes
Killip classification
Time frame: At 24 hours
New-onset atrial/ventricular arrhythmia
Time frame: At 30 days
New-onset atrial/ventricular arrhythmia
Time frame: From 30 days to 1 year
New diagnosis of heart failure
Time frame: At 30 days
New diagnosis of heart failure
Time frame: From 30 days to 1 year
Implantable Cardioverter Defibrillator (ICD) implantation
Time frame: At 1 year
Cardiac Re-synchronization Therapy/Defibrillator (CRT-D) implantation
Time frame: At 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided. Not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction (STEMI) Patients, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish H Shah, MD, MD-Res (UK),MRCP (204-237-2315, ashah5@sbgh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged hospitalization due to heart failure (> 96 hours) (time frame: At 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.