Cairo University hospitals
Cairo, 11815, Egypt
NCT Number: NCT05392777
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.
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Notify Me18 year–85 year
All sexes
Observational
Cairo, 11815, Egypt
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 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.
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.
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.
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 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)
Time frame: 6 months
Time frame: 6 months
clinical and imaging proven cerebrovascular stroke
Time frame: 6 months
For new myocardial infarction or unstable angina
Time frame: 6 months
Symptoms and signs consistent with heart failure diagnosis
Cairo University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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