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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02138604
Other study ID # dp/dt to detect AMD in ED
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2013
Est. completion date December 2016

Study information

Verified date July 2020
Source University of Monastir
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date December 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age over 18 year old

- Chest pain that lasted less than 12 hours

Exclusion Criteria:

- traumatic chest pain

- arrythmias

- STEMI

Study Design


Locations

Country Name City State
Tunisia Nouira Semir Monastir CHU Fattouma Bourguiba

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary plethysmographic dP/dt cardiac output value in patients with acute chest pain 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.
at admission
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