Diastolic DysfunctionNCT04114474
Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
An observational study of Diastolic Dysfunction, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- TRANSTHORACIC ECHOCARDIOGRAPY
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 30 Dec 2018
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligibility for participating in the study was assessed before assignment by the attending physician in the anesthesia clinic . Patients above 60 years of age ASAI and ASA II were included in the study unless history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases were found as theses patients were excluded from the study.
Who may be able to join
- Patients above 60 years of age ASAI and ASA II were included
Who cannot join
- history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020
About this study
The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients.
- Conditions
- Diastolic Dysfunction
- Being tested
- TRANSTHORACIC ECHOCARDIOGRAPY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSTHORACIC ECHOCARDIOGRAPYDiagnostic test
TTE (Vivid I echocardiography machine General Electric Healthcare, Milwaukee, WI, USA) with a 3S-RS (1.5-3.6 MHz) transthoracic probe). was done by professional anesthesiologist following the :Hemodynamic Echocardiography Assessment in Real Time ( HEART) protocol. According to the clinical findings of TTE patients may be either free or have one or more of the following haemodynamic states normal, empty, vasodilated ,left ventricular systolic or diastolic failure, left ventricular systolic and diastolic failure, and right ventricular failure, valve stenosis or regurgitation of at least moderate severity
What is being measured
The primary outcome is the main question the study is designed to answer.
Lt. Ventricular EDV
Transthoracic echocardiography (TEE) LVEDV
Measured: Change from Baseline pre operative LVEDV to first day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Oct 2017
- Primary completion1 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
- Investigators
- ALAA A EALZOHRY, MD, Principal investigator, Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114474
- Sponsor's protocol ID
- transthoracic echocardiograpy
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
- ClinicalTrials.gov ID
- NCT04114474
- Acronym / sponsor ID
- transthoracic echocardiograpy
- Conditions
- Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 3 Oct 2019 (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.
The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligibility for participating in the study was assessed before assignment by the attending physician in the anesthesia clinic . Patients above 60 years of age ASAI and ASA II were included in the study unless history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases were found as theses patients were excluded from the study.
Key inclusion criteria (1 listed)
- Patients above 60 years of age ASAI and ASA II were included
Key exclusion criteria (1 listed)
- history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases.
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 |
|---|---|---|
| TRANSTHORACIC ECHOCARDIOGRAPYTTE (Vivid I echocardiography machine General Electric Healthcare, Milwaukee, WI, USA) with a 3S-RS (1.5-3.6 MHz) transthoracic probe). was done by professional anesthesiologist following the :Hemodynamic Echocardiography Assessment in Real Time ( HEART) protocol. According to the clinical findings of TTE patients may be either free or have one or more of the following haemodynamic states normal, empty, vasodilated ,left ventricular systolic or diastolic failure, left ventricular systolic and diastolic failure, and right ventricular failure, valve stenosis or regurgitation of at least moderate severity | Diagnostic test | – |
Primary outcome
Lt. Ventricular EDV
Time frame: Change from Baseline pre operative LVEDV to first day postoperative
Transthoracic echocardiography (TEE) LVEDV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
ALAA A EALZOHRY, MD principal investigator
Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute.
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 Diastolic Dysfunction, run by South Egypt Cancer Institute at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2019. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lt. Ventricular EDV (time frame: Change from Baseline pre operative LVEDV to first day postoperative). 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 18 Oct 2019.