Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04730778
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2021-01-26
Brief Title:
Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Contrast induced acute kidney injury has commonly been referred to as contrast induced nephropathy CIN defined as an increase in serum creatinine 25 or 05 mgdl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure1 CIN Which can potentially lead to acute kidney failure or mortality is still common among hospitalized patients In addition contrast medium exposure may lead to long-term outcomes such as dialysis-requiring renal failure or death2 The incidence of CIN ranges from 7 to 25 in different population subgroups based on the risk status Hence risk stratification has an important bearing in order to provide the appropriate preventive therapies to those high-risk individuals before and after contrast media exposure3
In the past several risk prediction models have been proposed to envisage the CIN incidence Mehran proposed a scoring system comprising eight variables which correlated well with the CIN risk Despite having a fair degree of accuracy complexity was one of the major limitations of such models4 Most predictive models for contrast induced nephropathy in clinical use have modest ability and are only applied to patients receiving contrast for coronary angiography Further research is needed to develop models that can better inform patient centered decision making as well as improve the use of preventive strategies for contrast induced nephropathy5
ST-elevation myocardial infarction STEMI is a clinical syndrome defined by characteristic symptoms of myocardial ischemia in association with persistent electrocardiographic ST elevation STE and subsequent release of biomarkers of myocardial necrosis1 STE is the single best immediately available surrogate marker for detecting acute complete coronary artery occlusion denoting a significant region of injured myocardium at imminent risk of irreversible infarction requiring immediate reperfusion therapy6
Primary percutaneous coronary interventionPCI if performed in a timely fashion is the recommended modality of reperfusion in STEMI cases as per guidelines ACC-ESC-STEMI revascularization Frequently baseline kidney functions are unknown nevertheless to maximize salvaging myocardial tissue for STEMI patients immediate reperfusion is prioritized over awaiting tests results Considering the systemic inflammatory response associated with STEMI and that commonly due to severe pain and agony those patients are not properly hydrated added to higher prevalence of MI-related myocardial dysfunction and heart failure than in elective cases primary PCI for STEMI cases might have higher risk than usual of CIN78
The CHA2DS2-VASC score is traditionally used for embolic risk stratification in atrial fibrillation AF patients and includes the following variables congestive heart failure CHF hypertension age 75 years diabetes mellitus DM previous stroke vascular disease age 65 to 74 years and sex9
The CHA2DS2-VASC score has been reported recently to have a prognostic utility to predict adverse clinical outcomes in patients with acute coronary syndrome ACS regardless of having AF10
The CHA2DS2VASC score is practical and easy to memorize and apply in STEMI cases however strong evidence to validate its prognostic value in predicting CIN in the setting acute STEMI is lacking
In the past several risk prediction models have been proposed to envisage the CIN incidence Mehran proposed a scoring system comprising eight variables which correlated well with the CIN risk Despite having a fair degree of accuracy complexity was one of the major limitations of such models4 Most predictive models for contrast induced nephropathy in clinical use have modest ability and are only applied to patients receiving contrast for coronary angiography Further research is needed to develop models that can better inform patient centered decision making as well as improve the use of preventive strategies for contrast induced nephropathy5
ST-elevation myocardial infarction STEMI is a clinical syndrome defined by characteristic symptoms of myocardial ischemia in association with persistent electrocardiographic ST elevation STE and subsequent release of biomarkers of myocardial necrosis1 STE is the single best immediately available surrogate marker for detecting acute complete coronary artery occlusion denoting a significant region of injured myocardium at imminent risk of irreversible infarction requiring immediate reperfusion therapy6
Primary percutaneous coronary interventionPCI if performed in a timely fashion is the recommended modality of reperfusion in STEMI cases as per guidelines ACC-ESC-STEMI revascularization Frequently baseline kidney functions are unknown nevertheless to maximize salvaging myocardial tissue for STEMI patients immediate reperfusion is prioritized over awaiting tests results Considering the systemic inflammatory response associated with STEMI and that commonly due to severe pain and agony those patients are not properly hydrated added to higher prevalence of MI-related myocardial dysfunction and heart failure than in elective cases primary PCI for STEMI cases might have higher risk than usual of CIN78
The CHA2DS2-VASC score is traditionally used for embolic risk stratification in atrial fibrillation AF patients and includes the following variables congestive heart failure CHF hypertension age 75 years diabetes mellitus DM previous stroke vascular disease age 65 to 74 years and sex9
The CHA2DS2-VASC score has been reported recently to have a prognostic utility to predict adverse clinical outcomes in patients with acute coronary syndrome ACS regardless of having AF10
The CHA2DS2VASC score is practical and easy to memorize and apply in STEMI cases however strong evidence to validate its prognostic value in predicting CIN in the setting acute STEMI is lacking
Detailed Description:
- Methodology in details
All patients with ST elevation myocardial infarction who meets the inclusion criteria will be subjected to
A Full history taking including age sex history of DM HTN Smoking dyslipidemia history of cerebrovascular stroke family history of renal problems as well as time of onset of chest pain and time to reperfusion Regular medications and any nephrotoxic administration within the prior week to the index event will be reported
B Targeted physical examination
General examination and cardiac examination to detect signs of heart failure andor signs suggestive of mechanical complications
C Twelve lead ECG To diagnose ST elevation myocardial infarction Diagnostic STE is defined as new STE at the J point in at least 2 contiguous leads 2 mm 02 mV in men or 15 mm 015 mV in women in leads V2-V3 andor of 1 mm 01 mV in other contiguous chest or limb leads3 The presence of reciprocal changes manifested as ST depression in a region that approximates the vector 180 degrees opposite the major vessel of injury increases the specificity of STE caused by STEMI4
D Collecting baseline venous blood samples for Random blood glucose Hemoglobin serum creatinine and GFR before the procedure to be noted that reperfusion by primary PCI will not await tests results to be available
E Coronary angiography and primary PCI will be done by the interventional cardiologist as per standard technique After the procedure the volume of used contrast agent will be reported
F Echocardiography will be performed within 48 hours after the primary PCI to assess systolic diastolic and valvular functions
G Follow up of serum creatinine 12 hours after the procedure then daily till time of discharge
H CHA2DS2-VASC score will be calculated for each patient Based on the CHA2DS2-VASC score patients are given 1 point foreach of the following risk factors CHF hypertension age 65 to 74 years diabetes mellitus vascular disease and female gender and 2 points for age 75 years or older and previous stroke or transient ischemic attack
I Mehran risk score will be also calculated that risk score includes 8 prognostic variables
hypotension 5 points if systolic blood pressure 80 mmHg for at least 1 hour requiring inotropic support
use of intra-aortic balloon pump 5 points
CHF 5 points if class IIIIV by New York Heart Association Classification or history of pulmonary edema
age 4 points if 75 years
anemia 3 points if hematocrit 39 for men and 36 for women
diabetes mellitus 3 points
contrast media volume 1 point per 100 ml
estimated GFR 2 points if GFR 60 to 40 mlmin per 173 m2 4 points if GFR 40 to 20 6 points if GFR 20
Four categories of CIN risk of were established from the cut-off points and intervals defined by Mehran et al 2010 as follow
1 Low 5 points
2 Moderate 6 to 10 points
3 High 11 to 15 points
4 Very high 15 points Patients who develop CIN will have their characteristics studied as well as their CHA2DS2VASC score MEHRAN score and their individual components to be compared to those who did not develop primary PCI related CIN
All patients with ST elevation myocardial infarction who meets the inclusion criteria will be subjected to
A Full history taking including age sex history of DM HTN Smoking dyslipidemia history of cerebrovascular stroke family history of renal problems as well as time of onset of chest pain and time to reperfusion Regular medications and any nephrotoxic administration within the prior week to the index event will be reported
B Targeted physical examination
General examination and cardiac examination to detect signs of heart failure andor signs suggestive of mechanical complications
C Twelve lead ECG To diagnose ST elevation myocardial infarction Diagnostic STE is defined as new STE at the J point in at least 2 contiguous leads 2 mm 02 mV in men or 15 mm 015 mV in women in leads V2-V3 andor of 1 mm 01 mV in other contiguous chest or limb leads3 The presence of reciprocal changes manifested as ST depression in a region that approximates the vector 180 degrees opposite the major vessel of injury increases the specificity of STE caused by STEMI4
D Collecting baseline venous blood samples for Random blood glucose Hemoglobin serum creatinine and GFR before the procedure to be noted that reperfusion by primary PCI will not await tests results to be available
E Coronary angiography and primary PCI will be done by the interventional cardiologist as per standard technique After the procedure the volume of used contrast agent will be reported
F Echocardiography will be performed within 48 hours after the primary PCI to assess systolic diastolic and valvular functions
G Follow up of serum creatinine 12 hours after the procedure then daily till time of discharge
H CHA2DS2-VASC score will be calculated for each patient Based on the CHA2DS2-VASC score patients are given 1 point foreach of the following risk factors CHF hypertension age 65 to 74 years diabetes mellitus vascular disease and female gender and 2 points for age 75 years or older and previous stroke or transient ischemic attack
I Mehran risk score will be also calculated that risk score includes 8 prognostic variables
hypotension 5 points if systolic blood pressure 80 mmHg for at least 1 hour requiring inotropic support
use of intra-aortic balloon pump 5 points
CHF 5 points if class IIIIV by New York Heart Association Classification or history of pulmonary edema
age 4 points if 75 years
anemia 3 points if hematocrit 39 for men and 36 for women
diabetes mellitus 3 points
contrast media volume 1 point per 100 ml
estimated GFR 2 points if GFR 60 to 40 mlmin per 173 m2 4 points if GFR 40 to 20 6 points if GFR 20
Four categories of CIN risk of were established from the cut-off points and intervals defined by Mehran et al 2010 as follow
1 Low 5 points
2 Moderate 6 to 10 points
3 High 11 to 15 points
4 Very high 15 points Patients who develop CIN will have their characteristics studied as well as their CHA2DS2VASC score MEHRAN score and their individual components to be compared to those who did not develop primary PCI related CIN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None