Cardiovascular Diseases Clinical Trial
To examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in plasma samples collected at baseline from healthy participants in the Physicians' Health Study (PHS).
BACKGROUND:
The PHS is a cohort which included 14,916 men initially free of cardiovascular disease and
cancer who provided plasma samples at study entry in 1982. These men were randomly assigned
in a factorial design to aspirin or beta-carotene therapy, and have been followed
prospectively for the occurrence of vascular disease.
DESIGN NARRATIVE:
Employing a nested case-control design, baseline plasma samples are assayed for four markers
of inflammation (interleukin-6, TNF-alpha, soluble ICAM, soluble VCAM) and four markers of
chronic infection (antibody titers directed against Chlamydia pneumoniae, Helicobacter
pylori, Herpes simplex virus, and cytomegalovirus). Case subjects are those study
participants who have subsequently developed MI (N=550), CVA (N=400), or VTE (N=200).
Control subjects are selected from those study participants who remained healthy during
follow-up and are matched to the cases by age, smoking status, and follow-up time. Data on
usual cardiovascular risk factors, lipid parameters, and hemostatic markers of risk are
already available in the PHS and will be used to evaluate the results for potential
confounding and effect modification. Since the PHS was a randomized trial of low-dose
aspirin for its initial 5 years, this cohort also provides the unique opportunity to
investigate whether the use of an agent with anti-inflammatory properties modifies the risk
of subsequent thrombosis among those with underlying inflammation. Indeed, this intriguing
hypothesis has recently been raised regarding data relating another marker of inflammation,
C-reactive protein, to future risks of myocardial infarction and stroke.
These analyses will take advantage of an existing blood bank from a well-characterized large
cohort with many years of follow-up and high quality end-point verification. Thus, this
study could provide an efficient and cost-effective mechanism to evaluate the posited, but
unproven roles of inflammation and infection as risk factors for future cardiovascular
disease.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|