Myocardial InfarctionNCT05392777
Utility of Residual Syntax Score to Predict Outcome After Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the utility of residual syntax score after PCI of the culprit vessel for patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Residual syntax score
- How many people
- 490 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Jul 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Human participants of both genders, above the age of 18 years, with acute myocardial infarction (STEMI and NSTEMI) coming for primary or urgent PCI, who accept to participate to this observational study.
Who may be able to join
- Acute myocardial infarction (STEMI or NSTEMI)
Who cannot join
- Refusal to participate in the study.
- In case of NSTEMI, patients with unrecognizable culprit lesion will be excluded.
- Patients with previous coronary bypass surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the utility of residual syntax score after PCI of the culprit vessel for patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes.
Read the detailed description
A- Study Design: Prospective cross-sectional analytic study
B- Study Protocol: After attaining written informed consents from eligible STEMI/NSTEMI patients for participation in this observational study, data collection will be as follows: -
- Targeted history taking emphasizing on:
- Age of the patient, gender, and other risk-factors as hypertension, diabetes mellitus, smoking, substance abuse, dyslipidemia or family history of premature CAD.
- Symptoms as chest pain and time of onset, previous CAD related symptoms, therapies or revascularization procedures.
- Any relevant comorbid conditions.
- Time delays labelled as patient related delay, door-to-first medical contact, any delays of transfer, door-to-needle or -to-wire crossing will be recorded.
- Examination: Targeted physical examination of the patients with special emphasis on heart rate, blood pressure at presentation, Killip class (I-to-IV), signs suggestive of mechanical complications (new murmurs, pulmonary edema or cardiogenic shock). Patient weight and height will be collected to assess for overweight and/or obesity.
- Standard 12-leads surface electrocardiogram (ECG): It will be obtained to as part of initial diagnosis, identify rhythm disturbances (heart block or any other arrythmias). Non-standard ECG (right or posterior leads positioning) would be ordered as appropriate.
- Echocardiography: A rapid targeted bed-side study will be performed pre-cath as appropriate to assess LV-systolic function, regional wall motion abnormalities and any mechanical complication. Priority will be clearly for reperfusion, thus if the bed-side study would result in further delay, it will not be performed. All patients will have a formal and complete echo study before hospital discharge.
- Laboratory data: Venous blood sample will be obtained from all patients for biochemistry analysis. Cardiac biomarkers, complete blood count, coagulation profile, liver and kidney function testing, lipid-profile, CRP and glycated hemoglobin (HbA1c).
- Coronary angiography:
Coronary angiography and PCI is considered the gold-standard modality of revascularization for ST-segment Elevation myocardial infarction and is recommended within 24 hours for the majority patients presenting with NSTEMI.
Coronary angiography and PCI will be performed according to standard protocol. Culprit vessel, culprit lesion type and characteristics, initial and final TIMI flow, presence and number of non-culprit lesions will be collected and tabulated. Residual syntax score (rSS), as a surrogate for non-culprit atherosclerotic disease burden, will be equated as the conventional syntax score but subtracting the score of the culprit lesion(s) that have been passivated in the index procedure.
C- Follow-up Patients will be followed up for at least six-months to ensure compliance to medical therapy and life style interventions, and to report outcome measures accurately, including major adverse cardiac events (MACE), rehospitalization, target lesion revascularization, other unplanned revascularization and/or heart failure.
D- Data analysis By the end of the study period, the residual syntax score (rSS) will be used as a stratification tool to assess its correlation with outcome parameters.
- Conditions
- Myocardial Infarction
- Being tested
- Residual syntax score
- Keywords
- Residual syntax score, STEMI, NSTEMI, Myocardial infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residual syntax scoreDiagnostic test
residual syntax score will be calculated as the conventional syntax score from the web based tool, but subtract the score of the culprit lesion(s) that are fixed (stented) in the index procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse cardiovascular events (MACE).
Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)
Measured: 6 months
Secondary outcomes (4)
Rates of myocardial infarction
Measured: 6 months
Rates of cerebrovascular stroke
clinical and imaging proven cerebrovascular stroke
Measured: 6 months
Rates of ischaemia-deriven unplanned revascularization
For new myocardial infarction or unstable angina
Measured: 6 months
Rates of heart failure manifestations
Symptoms and signs consistent with heart failure diagnosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Samir, Cairo University
- Investigators
- Ahmad Samir, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392777
- Sponsor's protocol ID
- MS-2-221
- Status last verified
- Feb 2023
- First submitted
- 23 May 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Residual Syntax Score to Predict Outcome After Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05392777
- Acronym / sponsor ID
- MS-2-221
- Conditions
- Myocardial Infarction
- Keywords
- Residual syntax score, STEMI, NSTEMI, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 26 May 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.
The aim of this study is to evaluate the utility of residual syntax score after PCI of the culprit vessel for patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes.
Detailed description
A- Study Design: Prospective cross-sectional analytic study
B- Study Protocol: After attaining written informed consents from eligible STEMI/NSTEMI patients for participation in this observational study, data collection will be as follows: -
- Targeted history taking emphasizing on:
- Age of the patient, gender, and other risk-factors as hypertension, diabetes mellitus, smoking, substance abuse, dyslipidemia or family history of premature CAD.
- Symptoms as chest pain and time of onset, previous CAD related symptoms, therapies or revascularization procedures.
- Any relevant comorbid conditions.
- Time delays labelled as patient related delay, door-to-first medical contact, any delays of transfer, door-to-needle or -to-wire crossing will be recorded.
- Examination: Targeted physical examination of the patients with special emphasis on heart rate, blood pressure at presentation, Killip class (I-to-IV), signs suggestive of mechanical complications (new murmurs, pulmonary edema or cardiogenic shock). Patient weight and height will be collected to assess for overweight and/or obesity.
- Standard 12-leads surface electrocardiogram (ECG): It will be obtained to as part of initial diagnosis, identify rhythm disturbances (heart block or any other arrythmias). Non-standard ECG (right or posterior leads positioning) would be ordered as appropriate.
- Echocardiography: A rapid targeted bed-side study will be performed pre-cath as appropriate to assess LV-systolic function, regional wall motion abnormalities and any mechanical complication. Priority will be clearly for reperfusion, thus if the bed-side study would result in further delay, it will not be performed. All patients will have a formal and complete echo study before hospital discharge.
- Laboratory data: Venous blood sample will be obtained from all patients for biochemistry analysis. Cardiac biomarkers, complete blood count, coagulation profile, liver and kidney function testing, lipid-profile, CRP and glycated hemoglobin (HbA1c).
- Coronary angiography:
Coronary angiography and PCI is considered the gold-standard modality of revascularization for ST-segment Elevation myocardial infarction and is recommended within 24 hours for the majority patients presenting with NSTEMI.
Coronary angiography and PCI will be performed according to standard protocol. Culprit vessel, culprit lesion type and characteristics, initial and final TIMI flow, presence and number of non-culprit lesions will be collected and tabulated. Residual syntax score (rSS), as a surrogate for non-culprit atherosclerotic disease burden, will be equated as the conventional syntax score but subtracting the score of the culprit lesion(s) that have been passivated in the index procedure.
C- Follow-up Patients will be followed up for at least six-months to ensure compliance to medical therapy and life style interventions, and to report outcome measures accurately, including major adverse cardiac events (MACE), rehospitalization, target lesion revascularization, other unplanned revascularization and/or heart failure.
D- Data analysis By the end of the study period, the residual syntax score (rSS) will be used as a stratification tool to assess its correlation with outcome parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Human participants of both genders, above the age of 18 years, with acute myocardial infarction (STEMI and NSTEMI) coming for primary or urgent PCI, who accept to participate to this observational study.
Key inclusion criteria (1 listed)
- Acute myocardial infarction (STEMI or NSTEMI)
Key exclusion criteria (3 listed)
- Refusal to participate in the study.
- In case of NSTEMI, patients with unrecognizable culprit lesion will be excluded.
- Patients with previous coronary bypass surgery.
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 |
|---|---|---|
| Residual syntax scoreresidual syntax score will be calculated as the conventional syntax score from the web based tool, but subtract the score of the culprit lesion(s) that are fixed (stented) in the index procedure. | Diagnostic test | – |
Primary outcome
Composite of major adverse cardiovascular events (MACE).
Time frame: 6 months
Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)
4 secondary outcomes
Rates of myocardial infarction
Time frame: 6 months
Rates of cerebrovascular stroke
Time frame: 6 months
Rates of ischaemia-deriven unplanned revascularization
Time frame: 6 months
Rates of heart failure manifestations
Time frame: 6 months
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 8 Feb 2023.
- 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.
Ahmad Samir, MD principal investigator
Cairo University
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 Myocardial Infarction, run by Cairo University 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 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: finished, as of the sponsor's last update on 8 Feb 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 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?
Composite of major adverse cardiovascular events (MACE). (time frame: 6 months). 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 8 Feb 2023.