- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06521801
Cardio-Renal Registry (BHCRR)
Barts Health Cardio-Renal Registry
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Krishnaraj Rathod, MBBS, PhD
- Phone Number: 02073777000
- Email: k.s.rathod@qmul.ac.uk
Study Locations
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-
-
London, United Kingdom, EC1A 7BE
- Recruiting
- Barts Health NHS Trust
-
Contact:
- Krishnaraj Rathod, MBBS, PhD
- Phone Number: 02073777000
- Email: k.s.rathod@qmil.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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:
- Both male and female patients ≥16 years of age will be included
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with Renal Disease or Cardiology Disease
This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients with renal disease and cardiac disease.
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Observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality
Time Frame: 30 days and 1 year
|
30 days and 1 year
|
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Re-admission rates
Time Frame: 30 days and 1 year
|
30 days and 1 year
|
|
Major Adverse Cardiac Events
Time Frame: 30 days and 1 year
|
30 days and 1 year
|
|
Major Adverse Kidney Events
Time Frame: 30 days and 1 year
|
30 days and 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Chronic Disease
- Disease Attributes
- Infarction
- Necrosis
- Renal Insufficiency
- Myocardial Ischemia
- Ischemia
- Renal Insufficiency, Chronic
- Heart Failure
- Pathological Conditions, Signs and Symptoms
- Stroke
- Kidney Failure, Chronic
- Myocardial Infarction
- Cardio-Renal Syndrome
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- BHCRR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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