Clinical trial NCT06521801: Cardio-Renal Registry
Official title: Barts Health Cardio-Renal Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Renal Disease
Cardio-Renal Syndrome
Myocardial Infarction
Cerebrovascular Accident
Percutaneous Coronary Intervention
Dialysis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 60000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include all patients admitted to or reviewed at The Royal London Hospital (RLH) who have renal disease. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients will include those who have end stage renal disease, seen in the low clearance clinic, are on dialysis, are on the renal transplant list and who are post renal transplant.

Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

Brief summary: Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \<60 mL/min/1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the "treatment risk paradox," has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.


Eligibility criteria: Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Nephrology team.

Inclusion Criteria:

1. Both male and female patients ≥16 years of age will be included
2. All patients will be reviewed by the Nephrology team a the RLH with renal disease.

Exclusion Criteria:

1. Patients \<16 years will not be included in this study.

Primary outcomes:
measure: Mortality
timeFrame: 30 days and 1 year
measure: Re-admission rates
timeFrame: 30 days and 1 year
measure: Major Adverse Cardiac Events
timeFrame: 30 days and 1 year
measure: Major Adverse Kidney Events
timeFrame: 30 days and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References: