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临床试验/NCT07589374
NCT07589374尚未招募不适用

Correlation Between Carotid-Femoral Pulse Wave Velocity and Triglyceride-Glucose Index and Its Derived Metrics

Hospital de Base1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
试验地点
1
主要终点
Carotid-femoral pulse wave velocity (cf-PWV)

研究概览

简要总结

This study aims to investigate how metabolic health is related to arterial stiffness and daily blood pressure patterns. High blood pressure is one of the leading causes of heart disease worldwide, but cardiovascular risk is not determined only by average blood pressure values. Changes in blood vessel structure and metabolic function also play an important role in the development of cardiovascular disease.

Arterial stiffness reflects how flexible or rigid the arteries are. It can be measured using carotid-femoral pulse wave velocity (cf-PWV), which is considered a reliable and widely used method to assess vascular health. Increased arterial stiffness is associated with aging and higher cardiovascular risk.

At the same time, metabolic factors such as insulin resistance and central obesity are strongly linked to vascular damage. The triglyceride-glucose (TyG) index is a simple measure derived from routine blood tests and has been shown to reflect insulin resistance. Additional derived indices that combine TyG with body measurements (such as waist circumference and body mass index) may provide an even more comprehensive evaluation of metabolic risk.

Another important aspect of cardiovascular regulation is how blood pressure changes throughout the day. Blood pressure naturally rises in the morning after waking, a phenomenon known as the morning blood pressure surge. When this increase is excessive, it has been associated with a higher risk of cardiovascular events such as stroke and heart attack.

This study will evaluate the relationship between metabolic indices, arterial stiffness, and morning blood pressure patterns in adults undergoing ambulatory blood pressure monitoring as part of routine clinical care. The study will include both previously collected data and new participants evaluated using standardized methods.

No additional interventions will be performed, and all data will be collected as part of routine clinical evaluation. The results of this study may help improve cardiovascular risk assessment by integrating simple metabolic markers with vascular measurements and daily blood pressure behavior, potentially allowing earlier identification of individuals at higher risk.

详细描述

Introduction

Hypertension remains a major global health problem and a leading contributor to cardiovascular morbidity and mortality. Large epidemiological studies have demonstrated a continuous and graded relationship between blood pressure levels and cardiovascular events, including myocardial infarction, stroke, and heart failure. However, traditional office blood pressure measurements do not fully capture the complexity of cardiovascular risk.

Arterial stiffness has emerged as a key marker of vascular aging and cardiovascular risk. Carotid-femoral pulse wave velocity (cf-PWV) is considered the gold standard non-invasive method for assessing aortic stiffness. Increased cf-PWV reflects cumulative vascular damage resulting from structural and functional alterations in the arterial wall, including elastin degradation, collagen deposition, vascular calcification, and endothelial dysfunction.

Insulin resistance is a central mechanism linking metabolic disorders to vascular dysfunction. It is associated with reduced nitric oxide bioavailability, increased sympathetic activity, chronic low-grade inflammation, and vascular remodeling. The triglyceride-glucose (TyG) index has been validated as a reliable surrogate marker of insulin resistance and has shown consistent associations with cardiometabolic outcomes.

Derived indices incorporating anthropometric parameters, such as TyG-WC, TyG-BMI, and TyG-WHtR, have been proposed to better capture the interaction between metabolic dysfunction and central adiposity. In addition, composite indices such as the body roundness index (BRI), metabolic score for insulin resistance (METS-IR), and cardiometabolic index (CMI) integrate multiple physiological domains and may provide incremental value in cardiovascular risk stratification.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 65 years;
  • Both sexes;
  • Referred for ambulatory blood pressure monitoring (ABPM) as part of routine clinical evaluation;
  • Not receiving antihypertensive medication at the time of assessment;
  • Availability of valid 24-hour ABPM data;
  • Availability of carotid-femoral pulse wave velocity (cf-PWV) measurement;
  • Availability of fasting laboratory data, including glucose and triglycerides, for calculation of the triglyceride-glucose (TyG) index;
  • Ability and willingness to provide written informed consent (for prospectively recruited participants).

排除标准

  • Use of antihypertensive medication at the time of evaluation;
  • Cardiac arrhythmias that may interfere with accurate blood pressure or pulse wave velocity measurements;
  • Invalid or poor-quality ambulatory blood pressure monitoring (ABPM) recordings;
  • Inability to obtain reliable carotid-femoral pulse wave velocity (cf-PWV) measurements;
  • Presence of severe vascular disease or conditions affecting arterial waveform assessment;
  • Missing essential clinical, laboratory, or hemodynamic data required for the primary analysis;
  • Pregnancy;
  • Refusal or inability to provide informed consent (for prospectively recruited participants).

研究组 & 干预措施

Normotensive participants

Adults with normal 24-hour blood pressure based on ABPM (< 130/80 mmHg)

Untreated hypertensive participants

Adults with elevated 24-hour blood pressure (≥130/80 mmHg) not receiving antihypertensive treatment.

结局指标

主要结局

Carotid-femoral pulse wave velocity (cf-PWV)

时间窗: Baseline

Carotid-femoral pulse wave velocity (cf-PWV) will be measured as a marker of arterial stiffness using a validated non-invasive device under standardized conditions. The association between cf-PWV and the triglyceride-glucose (TyG) index will be evaluated.

次要结局

  • Morning systolic blood pressure(Average systolic blood pressure during the first two hours after awakening, obtained from 24-hour ambulatory blood pressure monitoring (ABPM).)
  • Morning diastolic blood pressure(Average diastolic blood pressure during the first two hours after awakening, obtained from ABPM.)
  • Sleep-through morning blood pressure surge(Difference between morning systolic blood pressure and the lowest nocturnal systolic blood pressure value.)
  • Prewaking morning blood pressure surge(Difference between morning systolic blood pressure and the average systolic blood pressure during the two hours preceding awakening.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JOSE FERNANDO VILELA-MARTIN

PhD

Hospital de Base

研究点 (1)

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