Coronary Microvascular Dysfunction (CMD)SHR-CMD-CCSNCT06698432
SHR Predicts CMD in Patients with CCS
An observational study of Coronary Microvascular Dysfunction (CMD) and Index of Microvascular Resistance, run by Ya-Wei Xu.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction (CMD), Index of Microvascular Resistance, Chronic Coronary Syndrome
- What is being tested?
- caIMR
- Type of treatment
- Medical device
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (1)Patients aged over 18 years (2)Patients diagnosed as suspected or established CCS[PMID: 39210710]who subsequently underwent coronary angiography (CAG).
Who cannot join
- (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.
- Suboptimal quality of angiography images, evident vascular overlap, distortion of the investigated artery or low contrast opacification
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Microvascular Dysfunction (CMD), Index of Microvascular Resistance, Chronic Coronary Syndrome, Prognosis
- Being tested
- caIMR
- Keywords
- Coronary Microvascular Dysfunction (CMD), Coronary angiography-derived index of microvascular resistance, Chronic coronary syndrome, Stress hyperglycemia ratio, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caIMRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CMD | Microvascular function was assessed using caIMR, CMD was identified with caIMR>25U, in line with prior research. Receives: Device: caIMR | |
| non-CMD | Microvascular function was assessed using caIMR, non-CMD was identified with caIMR≤25U, in line with prior research. Receives: Device: caIMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jun 2015
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Microvascular Dysfunction (CMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ya-Wei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698432
- Sponsor's protocol ID
- SHR-CMD-CCS
- Acronym
- SHR-CMD-CCS
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alifu J, Mamuti H, Luo Y, Wang C, Zhang W, Qi P, Mohammed AQ, Liu L, Yin G, Lv X, Shi T, Abdu FA, Che W. Prognostic significance of stress hyperglycemia ratio in coronary microvascular dysfunction among chronic coronary syndrome patients. Front Cardiovasc Med. 2026 Jun 4;13:1740092. doi: 10.3389/fcvm.2026.1740092. eCollection 2026.
PubMed 42325667
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implications of Stress Hyperglycemia Ratio for the Prognosis of Coronary Microvascular Dysfunction in Patients with Chronic Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06698432
- Acronym / sponsor ID
- SHR-CMD-CCS / SHR-CMD-CCS
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Ya-Wei XuUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMD | – | Device: caIMRMicrovascular function was assessed using caIMR, CMD was identified with caIMR>25U, in line with prior research. |
| non-CMD | – | Device: caIMRMicrovascular function was assessed using caIMR, non-CMD was identified with caIMR≤25U, in line with prior research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (1)Patients aged over 18 years (2)Patients diagnosed as suspected or established CCS[PMID: 39210710]who subsequently underwent coronary angiography (CAG).
Key exclusion criteria (2 listed)
- (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.
- Suboptimal quality of angiography images, evident vascular overlap, distortion of the investigated artery or low contrast opacification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caIMRCoronary 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. | Device | CMD, non-CMD |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 42325667Alifu J, Mamuti H, Luo Y, Wang C, Zhang W, Qi P, Mohammed AQ, Liu L, Yin G, Lv X, Shi T, Abdu FA, Che W. Prognostic significance of stress hyperglycemia ratio in coronary microvascular dysfunction among chronic coronary syndrome patients. Front Cardiovasc Med. 2026 Jun 4;13:1740092. doi: 10.3389/fcvm.2026.1740092. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Dysfunction (CMD) and Index of Microvascular Resistance, run by Ya-Wei Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06698432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.