Acute ST Segment Elevation Myocardial InfarctionNCT04730778
Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
An observational study of Acute ST Segment Elevation Myocardial Infarction, run by Cairo University at 1 site in Egypt.
Trial 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 ≥0.5 mg/dl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure.1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- What is being tested?
- serum creatinine and estimated glomerular filtration rate, on daily basis
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 15 Apr 2023
- 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: * Gender : Both genders are eligible * Age range : 18-80 years old * Disease conditions: All patients with ST elevation myocardial infarction undergoing primary PCI.
Who may be able to join
- All patients with ST elevation myocardial infarction undergoing primary PCI between 18 and 80 years old will be enrolled in this study
Who cannot join
- Patients known to have ESRD.
- Patient refusal to participate or withdrawal of consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasralainy hospital, faculty of medicine, Cairo university
Cairo, 11562
About this study
Contrast induced acute kidney injury has commonly been referred to as contrast induced nephropathy (CIN) defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure.1. 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 death.2. 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 exposure.3.
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 models.4 .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 nephropathy.5.
Read more
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 necrosis.1 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 therapy.6.
Primary percutaneous coronary intervention(PCI) 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 CIN.7,8.
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 sex.9.
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 AF.10.
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.
Read the detailed description
- Methodology in details:
All patients with ST elevation myocardial infarction who meets the inclusion criteria will be subjected to:
- 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.
- Targeted physical examination:
- General examination and cardiac examination to detect signs of heart failure and/or 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 (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest or limb leads.3 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 STEMI.4 .
- 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.
- 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.
- Echocardiography: will be performed within 48 hours after the primary PCI to assess systolic, diastolic and valvular functions.
- Follow up of serum creatinine 12 hours after the procedure then daily till time of discharge.
- 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.
- 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 III/IV 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 ml/min per 1.73 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:
- Low, <5 points.
- Moderate, 6 to 10 points.
- High, 11 to 15 points.
- 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.
- Being tested
- serum creatinine and estimated glomerular filtration rate, on daily basis
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum creatinine and estimated glomerular filtration rate, on daily basisDiagnostic test
Assess establishing criteria of CIN through a week after primary PCI
| Study group | Role | What they receive |
|---|---|---|
| CIN | STEMI patients who develop CIN "contrast induced nephropathy" within 1 week from primary PCI. Receives: Diagnostic Test: serum creatinine and estimated glomerular filtration rate, on daily basis | |
| Control | STEMI patients who do not meet criteria of CIN through 1 week post primary PCI Receives: Diagnostic Test: serum creatinine and estimated glomerular filtration rate, on daily basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of CHA2DS2VASc score for prediction of contrast induced nephropathy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Apr 2021
- Primary completion15 Dec 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ST Segment Elevation 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Samir, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730778
- Sponsor's protocol ID
- MS-238-2020
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samir A, Gabra W, Alhossary H, Bakhoum S. Predictive value of CHA2DS2VASC score for contrast-induced nephropathy after primary percutaneous coronary intervention for patients presenting with acute ST-segment elevation myocardial infarction. Egypt Heart J. 2023 Jun 26;75(1):52. doi: 10.1186/s43044-023-00378-x.
PubMed 37358644
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT04730778
- Acronym / sponsor ID
- MS-238-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 29 Jan 2021 (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.
Contrast induced acute kidney injury has commonly been referred to as contrast induced nephropathy (CIN) defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dl from baseline within 48-72 hours with peak incidence 2-5 days after contrast exposure.1. 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 death.2. 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 exposure.3.
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 models.4 .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 nephropathy.5.
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 necrosis.1 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 therapy.6.
Primary percutaneous coronary intervention(PCI) 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 CIN.7,8.
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 sex.9.
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 AF.10.
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:
- 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.
- Targeted physical examination:
- General examination and cardiac examination to detect signs of heart failure and/or 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 (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest or limb leads.3 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 STEMI.4 .
- 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.
- 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.
- Echocardiography: will be performed within 48 hours after the primary PCI to assess systolic, diastolic and valvular functions.
- Follow up of serum creatinine 12 hours after the procedure then daily till time of discharge.
- 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.
- 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 III/IV 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 ml/min per 1.73 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:
- Low, <5 points.
- Moderate, 6 to 10 points.
- High, 11 to 15 points.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIN | – | Diagnostic Test: serum creatinine and estimated glomerular filtration rate, on daily basisSTEMI patients who develop CIN "contrast induced nephropathy" within 1 week from primary PCI. |
| Control | – | Diagnostic Test: serum creatinine and estimated glomerular filtration rate, on daily basisSTEMI patients who do not meet criteria of CIN through 1 week post primary PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Gender : Both genders are eligible * Age range : 18-80 years old * Disease conditions: All patients with ST elevation myocardial infarction undergoing primary PCI.
Key inclusion criteria (1 listed)
- All patients with ST elevation myocardial infarction undergoing primary PCI between 18 and 80 years old will be enrolled in this study
Key exclusion criteria (2 listed)
- Patients known to have ESRD.
- Patient refusal to participate or withdrawal of consent
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 |
|---|---|---|
| serum creatinine and estimated glomerular filtration rate, on daily basisAssess establishing criteria of CIN through a week after primary PCI | Diagnostic test | CIN, Control |
Primary outcome
Utility of CHA2DS2VASc score for prediction of contrast induced nephropathy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention
Time frame: one week
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 1 Sep 2023.
- Results publication: PubMed 37358644Samir A, Gabra W, Alhossary H, Bakhoum S. Predictive value of CHA2DS2VASC score for contrast-induced nephropathy after primary percutaneous coronary intervention for patients presenting with acute ST-segment elevation myocardial infarction. Egypt Heart J. 2023 Jun 26;75(1):52. doi: 10.1186/s43044-023-00378-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ST Segment Elevation 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 2 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 1 Sep 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?
Utility of CHA2DS2VASc score for prediction of contrast induced nephropathy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730778, which also lists 1 linked publication.
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 1 Sep 2023.