Acute Coronary SyndromeNCT03549481
Predictive Value of Risk Scores in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Left Ventricle Remodeling, run by shaimaa Mostafa at 1 site in Egypt.
Trial summary
role of different risk scores in acute coronary syndrome to predict left ventricular remodeling Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Left Ventricle Remodeling, Risk Scores
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jul 2018to Jan 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients of both gender with acute coronary syndrome
Who may be able to join
- patients with acute coronary syndrome
Who cannot join
- previous acute coronary syndrome previous PCI or CABG chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of TIMI, PURSUIT and GRACE Risk Scores in Predicting LV Remodeling in Patients With Acute Coronary Syndrome
role of different risk scores in acute coronary syndrome to predict left ventricular remodeling
Read the detailed description
patients with acute coronary syndrome (STEMI, NSTEMI, UA) will be included and different risk scores will be calculated for each patient.
after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score
- Keywords
- risk score, acute coronary syndrome, left ventricular remodelng
- Medical subject headings
- Acute Coronary Syndrome, Ventricular Remodeling
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular remodeling
end diastolic volume, end systolic volume, ejection fraction
Measured: 3 months
in hospital and short term outcme
re-infarction, death, arrhythmia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start9 Jul 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary 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)
Sponsor and investigators
- Lead sponsor
- shaimaa Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shaimaa Mostafa, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549481
- Sponsor's protocol ID
- 3 SH research
- Status last verified
- Aug 2018
- First submitted
- 25 May 2018
- Last updated
- 23 Aug 2018
- 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 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of TIMI, PURSUIT and GRACE Risk Scores in Predicting LV Remodeling in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03549481
- Acronym / sponsor ID
- 3 SH research
- Keywords
- risk score, acute coronary syndrome, left ventricular remodelng
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- shaimaa MostafaUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 8 Jun 2018 (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.
role of different risk scores in acute coronary syndrome to predict left ventricular remodeling
Detailed description
patients with acute coronary syndrome (STEMI, NSTEMI, UA) will be included and different risk scores will be calculated for each patient.
after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients of both gender with acute coronary syndrome
Key inclusion criteria (1 listed)
- patients with acute coronary syndrome
Key exclusion criteria (1 listed)
- previous acute coronary syndrome previous PCI or CABG chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up
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
left ventricular remodeling
Time frame: 3 months
end diastolic volume, end systolic volume, ejection fraction
in hospital and short term outcme
Time frame: 3 months
re-infarction, death, arrhythmia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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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.
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 Acute Coronary Syndrome and Left Ventricle Remodeling, run by shaimaa Mostafa 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: status not confirmed, as of the sponsor's last update on 23 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shaimaa A Mostafa, MD (01229122843 ext. 0020, shaimaamustafa2011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular remodeling (time frame: 3 months). 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 23 Aug 2018.