Frail Elderly SyndromeNCT03365505
Frailty Assessment in Elderly Patients With Acute Coronary Syndrome
An observational study of Frail Elderly Syndrome and Acute Coronary Syndrome, run by Meir Medical Center.
Trial summary
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the… Read more about this study
- Who is it for?
- Ages 80 to 120 years
- Conditions the study is for
- Frail Elderly Syndrome, Acute Coronary Syndrome
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2017to 15 Sep 2018
- How long will I take part?
- 1 Year
- 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 80 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly patient admitted to our hospital with acute coronary syndrome: unstable angina or non ST elevation myocardial infarction who are aged 80 and above and are hemodinamically stable.
Who may be able to join
- patient admitted to Meir hospital with acute coronary syndrome
- Age: 80 years old and older
- eligible for signing an informed concent
Who cannot join
- uncontrolled heart failure ( pulmonary edema or the use of iv diuretics)
- cardiogenic shock
- fever st elevation myocardial infarction
About this study
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing.
in this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.
Read the detailed description
elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale.
The cardiologist will not be aware of the objective frailty assessment result.
The eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).
- Conditions
- Frail Elderly Syndrome, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale
Subjective frailty assessment made by a cardiologist during hospitalization with acute coronary syndrome- "eye ball" testing
Measured: Through hospitalization , an average of 1 week
An objective frailty assessment using Fried score and Edmonton frailty scale will be compared to a subjective eye ball frailty assessment
An objective frailty assessment based on Fried score and Edmonton frailty scale
Measured: Through hospitalization , an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Dec 2017 (estimated)
- Primary completion15 Sep 2018 (estimated)
- Study completion15 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365505
- Sponsor's protocol ID
- 00-34-17-MMC
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment in Elderly Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03365505
- Acronym / sponsor ID
- 00-34-17-MMC
- Conditions
- Frail Elderly Syndrome, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 15 Dec 2017 (estimated)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 15 Sep 2018 (estimated)
- First posted
- 7 Dec 2017 (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.
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients . It is an important factor on the cardiologist decision between conservative and invasive treatment in older patient with acute coronary syndrome, and is usually made subjectively by the cardiologist known in the literature as eyeball testing.
in this study the investigators will compare the cardiologists eye ball testing to objective frailty assessment based on Fried score and Edmonton frailty scale.
Detailed description
elderly patients admitted to Meir hospital with acute coronary syndrome will be assessed for frailty twice: the first frailty assessment will be a subjective eye ball testing made by the cardiologist, the second assessment will be an objective one based on Fried frailty score and Edmonton frail scale.
The cardiologist will not be aware of the objective frailty assessment result.
The eye ball testing will be compared to the objective frailty assessment (Fried score and Edmonton frailty scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 80 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patient admitted to our hospital with acute coronary syndrome: unstable angina or non ST elevation myocardial infarction who are aged 80 and above and are hemodinamically stable.
Key inclusion criteria (3 listed)
- patient admitted to Meir hospital with acute coronary syndrome
- Age: 80 years old and older
- eligible for signing an informed concent
Key exclusion criteria (3 listed)
- uncontrolled heart failure ( pulmonary edema or the use of iv diuretics)
- cardiogenic shock
- fever st elevation myocardial infarction
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
A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale
Time frame: Through hospitalization , an average of 1 week
Subjective frailty assessment made by a cardiologist during hospitalization with acute coronary syndrome- "eye ball" testing
An objective frailty assessment using Fried score and Edmonton frailty scale will be compared to a subjective eye ball frailty assessment
Time frame: Through hospitalization , an average of 1 week
An objective frailty assessment based on Fried score and Edmonton frailty scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
Related trials for Frail Elderly Syndrome
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Frailty Syndrome, Older Adults
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome and Acute Coronary Syndrome, run by Meir Medical Center.
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 3 inclusion and 3 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
A subjective eye ball frailty assessment will be compared to an objective frailty assessment based on Fried score and Edmonton frailty scale (time frame: Through hospitalization , an average of 1 week). 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 7 Dec 2017.