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Non Invasive dP/dt to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department (dP/dtAMDED)

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ClinicalTrials.gov Identifier: NCT02138604
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

Brief Summary:

Most patients presenting to the emergency department with chest discomfort have a nonischemic ECG and biomarkers of myocardial necrosis within normal limits. These patients are routinely admitted to hospital because of diagnostic uncertainty for occult MI or ischaemia.

Acute myocardial ischemia is associated with acute mycardial dysfunction We tested a non-invasive plethysmographic arterial pressure change index of myocardial performance (dP/dt) that could be added to the diagnostic triage of ischaemia in the ER avoiding unnecessary admissions.


Condition or disease
Acute Myocardial Ischemia

Detailed Description:

For patients with chest pain , the ECG remains the most important initial risk assessment tool. Myocardial ischemia or infarction is highly likely in patients with significant ST segment changes on the ECG or elevation in myocardial markers of necrosis. Identification of high-risk patients is more difficult in those with non ischemic ECG and negative markers on presentation.

One of the most sensitive indices of contractility is the rate of increase of intraventricular pressure during isovolumetric contraction, (left ventricular dP/dt and arterial dP/dt). Dp/dt (dP/dt ejc ) represents the rate of change of pressure during ejection. It has been shown that cardiac contractility and dP/dt decreases during acute myocardial ischemia.

We theorized that a higher value of dP/dt would be found for non ischemic chest pain than during ischemic chest pain because ischemia reduces myocardial contractility, whereas chest pain of non cardiac origin increases dP/dt by the stress of the pain itself.

The current study describes a noninvasive plethysmographic dP/dt changes in patients presenting at the emergency department with acute chest pain, which could be added to the diagnostic triage of ischemia in the ED, thus decreasing the number of unnecessary admissions.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Non Invasive dP/dt is Not a Good Index to Detect an Acute Ischemic Myocardial Dysfunction in Emergency Department (ED)
Actual Study Start Date : June 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2016



Primary Outcome Measures :
  1. plethysmographic dP/dt cardiac output value in patients with acute chest pain [ Time Frame: at admission ]

    compare the noninvasive dP/dt values in the two study groups: Acute Coronary syndrome (ACS) and non ACS.

    the diagnostic of ischemic origin of chest pain is based on anamnestic, electrocardiographic, and necrosis enzymes.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients presenting to the emergency department with acute chest pain
Criteria

Inclusion Criteria:

  • age over 18 year old
  • Chest pain that lasted less than 12 hours

Exclusion Criteria:

  • traumatic chest pain
  • arrythmias
  • STEMI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138604


Locations
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Tunisia
Nouira Semir
Monastir, CHU Fattouma Bourguiba, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: semir Nouira, Pr University of Monastir
Additional Information:

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Responsible Party: Pr. Semir Nouira, Non invasive dP/dt is not a good index to detect an acute ischemic myocardial dysfunction in emergency department (ED), University of Monastir
ClinicalTrials.gov Identifier: NCT02138604    
Other Study ID Numbers: dp/dt to detect AMD in ED
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pr. Semir Nouira, University of Monastir:
chest pain
myocardial ischemia
acute myocardial dysfunction
plethesmography
non invasive dP/dt
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Emergencies
Ischemia
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases