SHR Predicts CMD in Patients with CCS (SHR-CMD-CCS)

November 19, 2024 updated by: Ya-Wei Xu

Prognostic Implications of Stress Hyperglycemia Ratio for the Prognosis of Coronary Microvascular Dysfunction in Patients with Chronic Coronary Syndrome

SHR exerts a significant influence in numerous cardiovascular diseases, including MINOCA (myocardial infarction with non - obstructive coronary arteries), HFpEF (heart failure with preserved ejection fraction), and CAD (coronary artery disease). It thereby demonstrates its predictive capacity regarding survival risk and its value in risk-stratification procedures. To date, no studies have specifically investigated the prognostic implications of the stress hyperglycemia ratio (SHR) in CMD patients with CCS, highlighting the need for further research. Therefore, this study seeks to evaluate the predictive value of the stress hyperglycemia ratio (SHR) in CMD patients with CCS, and to elucidate its clinical relevance and significance, which remain poorly understood in this patient cohort.

Study Overview

Detailed Description

Coronary artery disease (CAD), a cardiovascular disorder precipitated by the atherosclerotic narrowing or occlusion of the coronary arteries, culminates in myocardial ischemia, hypoxia, or necrosis. As one of the foremost causes of morbidity and mortality worldwide, CAD represents an escalating public health concern. Chronic coronary syndrome (CCS) refers to the stable, long-term clinical manifestations of coronary artery disease (CAD), representing a progressive and sustained phase of the condition. Coronary microvascular dysfunction (CMD) is characterized by alterations in the structure and function of the coronary microcirculation, a condition frequently encountered in clinical practice. The presence of CMD, particularly when associated with atherosclerosis, may exacerbate myocardial ischemia in patients with chronic coronary syndrome (CCS). CMD is prevalent across a broad range of cardiovascular conditions, including heart failure with preserved ejection fraction (HFpEF), Takotsubo syndrome (TTS), acute coronary syndrome (ACS), myocardial infarction with non-obstructive coronary arteries (MINOCA), and CCS. It plays a pivotal role in the pathophysiology and prognosis of these diseases. Substantial evidence indicates that coronary microvascular dysfunction (CMD) is prevalent in patients with chronic coronary syndrome (CCS) and is closely linked to the pathogenesis and unfavorable prognosis of the condition. Therefore, the diagnosis of CMD carries significant implications for the management of CCS patients and the prevention of adverse outcomes.

The molecular mechanisms of CMD are not yet fully understood, but impaired pathologic dilation or increased constriction of coronary microvessels due to oxidative stress and inflammatory responses are thought to be the vital causative mechanisms of CMD.Studies have demonstrated that hyperglycemic states play a crucial role in CMD by altering the oxygen demand of cardiomyocytes, which leads to abnormal vascular regulation.Stress-induced hyperglycemia may aggravate coronary microvascular dysfunction (CMD) through mechanisms such as the induction of endothelial dysfunction and the promotion of oxidative stress, thereby contributing to adverse outcomes. Acute hyperglycemia, often undetected due to the lack of precise and effective monitoring methods, may arise from either pre-existing chronic hyperglycemia or acute physiological stress, leading to a transient increase in blood glucose levels upon hospital admission. In these instances, the stress hyperglycemia ratio (SHR) has been proposed as a novel marker to more accurately reflect the acute hyperglycemic state. The SHR is defined as the ratio of the blood glucose level at admission to the estimated average chronic glycemic value. SHR exerts a significant influence in numerous cardiovascular diseases, including MINOCA (myocardial infarction with non - obstructive coronary arteries), HFpEF (heart failure with preserved ejection fraction), and CAD (coronary artery disease). It thereby demonstrates its predictive capacity regarding survival risk and its value in risk-stratification procedures. To date, no studies have specifically investigated the prognostic implications of the stress hyperglycemia ratio (SHR) in CMD patients with CCS, highlighting the need for further research. Therefore, this study seeks to evaluate the predictive value of the stress hyperglycemia ratio (SHR) in CMD patients with CCS, and to elucidate its clinical relevance and significance, which remain poorly understood in this patient cohort.

Study Type

Observational

Enrollment (Actual)

379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This single-center retrospective observational study were implemented in Shanghai Tenth People's Hospital spanning from June 2015 to June 2019. Our investigation received the endorsement of the Ethical Review Board of Shanghai Tenth People's Hospital and was carried out in line with the Helsinki Declaration. Each patient involved in this study was required to provide written informed consent.

Description

Inclusion Criteria:

  • (1)Patients aged over 18 years (2)Patients diagnosed as suspected or established CCS[PMID: 39210710]who subsequently underwent coronary angiography (CAG).

Exclusion Criteria:

- (1)A left ventricular ejection fraction (LVEF) lower than 35% (2)Recent occurrence of myocardial infarction (MI) (3)Severe hepatic or renal dysfunction (4)The existence of malignancy (5)Post-coronary artery bypass graft surgery (CABG) (6)Being in a current state of pregnancy (7)Incomplete data of SHR, (8)Non-adherence to follow-up protocols (9)Other life-threatening diseases that significantly impact long-term survival.

(10) Suboptimal quality of angiography images, evident vascular overlap, distortion of the investigated artery or low contrast opacification

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CMD
Microvascular function was assessed using caIMR, CMD was identified with caIMR>25U, in line with prior research.
Coronary angiography-derived IMR (caIMR) is a novel and accurate alternative that can enable the assessment of coronary microvascular function easier, and more efficiently and does not require pressure wire or adenosine.
non-CMD
Microvascular function was assessed using caIMR, non-CMD was identified with caIMR≤25U, in line with prior research.
Coronary angiography-derived IMR (caIMR) is a novel and accurate alternative that can enable the assessment of coronary microvascular function easier, and more efficiently and does not require pressure wire or adenosine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major adverse cardiac events (MACE)
Time Frame: Follow-up was conducted over a mean 43-month period through telephone calls, hospital records, and outpatient visits by trained physicians at Shanghai Tenth People's Hospital
We defined major adverse cardiac events (MACE) as the primary clinical endpoint of present investigation, which was a combination of following conditions: (1) Cardiac death: demise caused by malignant arrhythmia, acute MI, heart failure, or other cardiac diseases; (2) Ischemia-driven revascularization: revascularization due to recurrent angina or a positive cardiac ischemia test; (3) Nonfatal MI: presence of positive cardiac biomarkers along with typical myocardial ischemia symptoms or electrocardiogram dynamic changes; (4) Heart failure: clinical symptoms such as dyspnea, fatigue, etc., accompanied by positive evidence from echocardiography, BNP/NT-proBNP measurement, and cardiac function assessment; (5) Nonfatal stroke: acute cerebral infarction diagnosed by typical clinical symptoms or imaging examination.
Follow-up was conducted over a mean 43-month period through telephone calls, hospital records, and outpatient visits by trained physicians at Shanghai Tenth People's Hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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