Clinical trial NCT06698432: SHR Predicts CMD in Patients with CCS
Official title: Prognostic Implications of Stress Hyperglycemia Ratio for the Prognosis of Coronary Microvascular Dysfunction in Patients with Chronic Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Microvascular Dysfunction (CMD)
Index of Microvascular Resistance
Chronic Coronary Syndrome
Prognosis
Keywords: Coronary Microvascular Dysfunction (CMD)
Coronary angiography-derived index of microvascular resistance
Chronic coronary syndrome
Stress hyperglycemia ratio
Prognosis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: major adverse cardiac events (MACE)
timeFrame: 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
Secondary outcomes:
Other outcomes:
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