Chest Paindp/dtNCT05416112
Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients
An observational study of Chest Pain, run by University of Monastir at 1 site in Tunisia.
Trial summary
Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2022to 30 Sep 2023
- How long will I take part?
- 8 Months
- 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: patients presenting to the emergency department with acute chest pain
Who may be able to join
- age over 18 years old,
- acute chest pain
Who cannot join
- traumatic chest pain,
- hemodynamic instability;
- arrhythmias;
- holders of a pacemaker;
- STEMI
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Emergency Departement
Monastir, 5000
Semir Nouira, professor, 73 106 085 ext. 216, semir.nouira@rns.tn
semir nouira, professor
About this study
Official title: Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain
Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.
Read the detailed description
Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores.
The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase.
the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility.
The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.
- Conditions
- Chest Pain
- Keywords
- chest pain,, myocardial ischemia,, acute myocardial dysfunction,, plethysmography,, non invasive dp/dt.
- Medical subject headings
- Chest Pain, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
the occurrence of a major cardiovascular event (MACE)
Measured: one month
MACE
: the occurrence of a major cardiovascular event (MACE)
Measured: SIX MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jun 2022
- Primary completion31 May 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- 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)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, professor, Principal investigator, Monastir University Hospital, Monastir, Tunisia, 5000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416112
- Sponsor's protocol ID
- dp/dt
- Acronym
- dp/dt
- Status last verified
- May 2023
- First submitted
- 8 Jun 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain
- ClinicalTrials.gov ID
- NCT05416112
- Acronym / sponsor ID
- dp/dt / dp/dt
- Conditions
- Chest Pain
- Keywords
- chest pain,, myocardial ischemia,, acute myocardial dysfunction,, plethysmography,, non invasive dp/dt.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Jun 2022 (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.
Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.
Detailed description
Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores.
The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase.
the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility.
The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting to the emergency department with acute chest pain
Key inclusion criteria (2 listed)
- age over 18 years old,
- acute chest pain
Key exclusion criteria (5 listed)
- traumatic chest pain,
- hemodynamic instability;
- arrhythmias;
- holders of a pacemaker;
- STEMI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: one month
the occurrence of a major cardiovascular event (MACE)
MACE
Time frame: SIX MONTHS
: the occurrence of a major cardiovascular event (MACE)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Nouira Semir, professor principal investigator
Monastir University Hospital, Monastir, Tunisia, 5000
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 Chest Pain, run by University of Monastir at 1 site in Tunisia.
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 5 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 16 May 2023. 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 Tunisia. 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 Nouira Semir, professor (73106046 ext. 00216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: one month). The study lists 2 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 16 May 2023.