Last reviewed · How we verify
NCT03038750: CADBIO
Molecular Investigation of Genetic Factors in CArDiovascular Diseases Using an BIOresource of Healthy Volunteers
trial testing Eligibility and lifestyle restrictions check. in Cardiovascular Diseases in 74 participants. Terminated before completion.
6 June 2023
Quick facts
| Lead sponsor | Cambridge University Hospitals NHS Foundation Trust |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 74 |
| Start date | 14 August 2017 |
| Primary completion | 6 June 2023 |
| Estimated completion | 6 June 2023 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Eligibility and lifestyle restrictions check.
- Medical history, demographic and lifestyle factors
- Anthropometric measurements: height, weight, and body fat
- Blood pressure and heart rate
- Forearm blood flow: Visit 1 (EDNRA)
- Forearm blood flow: Visit 2 (EDNRA)
- Blood biochemistry (PNPLA3)
- Blood EPCR function (PROCR)
- Blood platelet coagulation and function (PROCR)
- Blood endothelial permeability (PROCR)
- Blood leukocyte-endothelium adhesion (PROCR)
- Baseline Venepuncture (PNPLA3, Visit 1)
- Deuterium water - Loading dose 1 (PNPLA3, Visit 1)
- Deuterium water - Loading dose 2 (PNPLA3, Visit 1)
- Energy-balanced dinner (PNPLA3, Visit 1)
- Fasting venepuncture (PNPLA3, Visit 2)
- Deuterium water - Maintenance dose (PNPLA3, Visit 2)
- Consumption of high carbohydrate meal (PNPLA3, Visit 2)
- Postprandial Venepuncture (PNPLA3, Visit 2)
- Venepuncture (PROCR)
Conditions studied
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Who can join
Adults 18 to 50, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. We are investigating three potential genetic risk factors in this observational, cross-sectional, epidemiology pilot study to investigate if and how functional variants identified in large-scale genome wide association studies can explain a predisposition to cardiovascular disease. By determining the molecular mechanisms that are regulated at the EDNRA, PNPLA3 and PROCR CVD risk loci, we hope to translate findings from this study into the clinical setting for better diagnosis, prevention and treatment for patients suffering with cardiovascular disease. Volunteers will enter into one of the study's three arms based on their genotype: EDNRA locus (Arm 1), PNPLA3 locus (Arm 2), or PROCR locus (Arm 3). Members of the Cambridge Bioresource who match for the target alleles will be invited to participate and will enter into one of the three study arms. All study assessment visits will take place at Addenbrooke's Hospital in collaboration with the University of Cambridge. Volunteers will participate in the study for a maximum of 12 months and depending on study arm they are assigned to, they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. Minimally invasive procedures including forearm blood flow and venepuncture will be performed to assess the primary objectives of the study. The hypothesis for arm 1 is that the genetic variant we are investigating at the EDNRA gene locus alters the function of the endothelin receptor A leading to an increased risk of coronary artery disease and large artery stroke. For study arm 2, we hypothesize that the genetic variant we are investigating in PNPLA3 will increase the risk of Non-alcoholic fatty liver disease but reduce the risk of Coronary Heart Disease. For study arm 3, we hypothesize that the genetic variant we are investigating in the PROCR locus triggers molecular events that potentially increase the risk of Venous Thrombosis/Venous Thromboembolism nut reducing blood pressure. Furthermore we aim to investigate the anti-inflammatory effects to see if there is an effect on explaining reduced risk of CHD. This study is funded from the BHF Cambridge Center of Excellence and the Wellcome Trust Institutional Strategic Support Fund.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03038750
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiovascular Diseases
Currently open trials in the same condition.
- NCT07442578 — Impact of Exercise Intensity on Cardiac Health in Young Adult Survivors of Childhood Cancer: The PULSE Trial · NA · active not recruiting
- NCT07426263 — Effectiveness of a Therapeutic Education Program on Female Sexuality in Women Attending Cardiac Rehabilitation. · NA · active not recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07324278 — Hybrid Stroke Rehab With Mirror Priming · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Cambridge University Hospitals NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07516496 — Metabolic Phenotyping in vEDS · recruiting
- NCT07129577 — Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury · not yet recruiting
- NCT05093231 — Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer · Phase 2 · recruiting
- NCT06555757 — Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation · not yet recruiting
- NCT06427694 — Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03038750 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cambridge University Hospitals NHS Foundation Trust
- Last refreshed: 2 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03038750.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing