NCT02138604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

April 8, 2014

Last Update Submit

July 17, 2020

Conditions

Acute Myocardial Ischemia

Keywords

chest painmyocardial ischemiaacute myocardial dysfunctionplethesmographynon invasive dP/dt

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the emergency department with acute chest pain

You may qualify if:

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

You may not qualify if:

  • traumatic chest pain
  • arrythmias
  • STEMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouira Semir

Monastir, CHU Fattouma Bourguiba, 5000, Tunisia

Location

MeSH Terms

Conditions

Chest PainMyocardial Ischemia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • semir Nouira, Pr

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Non invasive dP/dt is not a good index to detect an acute ischemic myocardial dysfunction in emergency department (ED)

Study Record Dates

First Submitted

April 8, 2014

First Posted

May 14, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2016

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)