SHR Predicts CMD in Patients with CCS

NCT06698432 | Completed DMC

• 1 other identifier: SHR-CMD-CCS
• Study Type: observational
• Target: 379
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac events (MACE)

  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

Study Arms (2)

CMD

Microvascular function was assessed using caIMR, CMD was identified with caIMR\>25U, in line with prior research.

Device: caIMR

non-CMD

Microvascular function was assessed using caIMR, non-CMD was identified with caIMR≤25U, in line with prior research.

Device: caIMR

Interventions

caIMR DEVICE

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.

CMD; non-CMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- (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

Sponsors & Collaborators

• Ya-Wei Xu: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: June 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share