Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients

NCT04730778 | Completed

• 1 other identifier: MS-238-2020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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 ≥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.

Conditions

Acute ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Utility of CHA2DS2VASc score for prediction of contrast induced nephropathy in patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention

  one week

Study Arms (2)

CIN

STEMI patients who develop CIN "contrast induced nephropathy" within 1 week from primary PCI.

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

Diagnostic Test: serum creatinine and estimated glomerular filtration rate, on daily basis

Interventions

serum creatinine and estimated glomerular filtration rate, on daily basis DIAGNOSTIC_TEST

Assess establishing criteria of CIN through a week after primary PCI

CIN; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All patients with ST elevation myocardial infarction undergoing primary PCI between 18 and 80 years old will be enrolled in this study

You may not qualify if:

• Patients known to have ESRD.
• Patient refusal to participate or withdrawal of consent

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralainy hospital, faculty of medicine, Cairo university

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37358644 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiology

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: April 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: April 15, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

EG (1)