Coronary Cicrovascular DysfunctioncaIMR-HCMNCT06190704
Prognostic Significance of CMD Assessed by IMR in HCM Patients
An observational study of Coronary Cicrovascular Dysfunction and Hypertrophic Cardiomyopathy Patients, run by Ya-Wei Xu.
Trial summary
The index of microcirculatory resistance (IMR) serves as an indicator of coronary microvascular dysfunction (CMD) with significant prognostic value in various clinical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Cicrovascular Dysfunction, Hypertrophic Cardiomyopathy Patients
- What is being tested?
- caIMR
- Type of treatment
- Medical device
- How many people
- 191 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2014to 31 May 2023
- 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
- Adult, Older adult
Study population: Patients diagnosed with HCM and referred to the catheterization lab at Shanghai Tenth People's Hospital between 2014 and 2023 for invasive coronary angiography (CAG) due to suspected myocardial ischemia were included in this single-center retrospective observational study
Who may be able to join
- Age >18 years old;
- echocardiographic evidence of HCM, defined as LV myocardial wall thickness of ≥15 mm and or a LV myocardial wall thickness of ≥13 mm in individuals with a family history of HCM, in the absence of an alternative cause for LV hypertrophy
Who cannot join
- significant mitral regurgitation;
- second and third-degree atrioventricular block;
- presence of significant epicardial coronary stenosis (≥50% stenosis) on CAG;
- poor life expectancy resulting from concurrent health disease.;
- reduced contrast opacification (for caIMR assessment)
About this study
Official title: Prognostic Significance of Coronary Microvascular Dysfunction Assessed by Microvascular Resistance in Hypertrophic Cardiomyopathy Patients
The index of microcirculatory resistance (IMR) serves as an indicator of coronary microvascular dysfunction (CMD) with significant prognostic value in various clinical conditions. However, its impact on CMD in the hypertrophic cardiomyopathy (HCM), whether assessed invasively or non-invasively, is yet to be investigated. We assessed the prognostic importance of CMD using less invasive coronary angiography-derived IMR (caIMR) in HCM patients with nonobstructive epicardial coronary arteries.Patients with HCM who underwent invasive coronary angiography for suspected myocardial ischemia were included. Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR>25U, in line with prior research, and the primary study endpoint was major adverse cardiac events (MACE).
Read the detailed description
Patients diagnosed with HCM and referred to the catheterization lab at Shanghai Tenth People's Hospital between 2014 and 2023 for invasive coronary angiography (CAG) due to suspected myocardial ischemia were included in this single-center retrospective observational study. The inclusion criteria of the present study were as follows: 1) Age >18 years old; 2) echocardiographic evidence of HCM, defined as LV myocardial wall thickness of ≥15 mm and or a LV myocardial wall thickness of ≥13 mm in individuals with a family history of HCM, in the absence of an alternative cause for LV hypertrophy. The exclusion criteria were: 1) significant mitral regurgitation; 2) second and third-degree atrioventricular block; 3) presence of significant epicardial coronary stenosis (≥50% stenosis) on CAG; 4) poor life expectancy resulting from concurrent health disease.; and 5) reduced contrast opacification (for caIMR assessment). Our study was conducted in accordance with the Helsinki Declaration and was approved by the ethical review board of Shanghai Tenth People's Hospital.
The essential clinical data, including age, gender, systolic and diastolic blood pressure, heart rate, as well as the past medical history encompassing diabetes, hypertension, hyperlipidemia, stroke, atrial fibrillation, heart failure, family history of HCM, syncope, and smoking history, were systematically recorded. Additionally, laboratory parameters such as total cholesterol, high- and low-density lipoprotein, triglycerides, and N-terminal pro-brain natriuretic peptide were documented. The cardiovascular medical medications, including beta-blockers, antiplatelet agents, ACE inhibitors/ARBs, calcium channel blockers, anticoagulants, diuretics, and amiodarone, for all participants were also noted. Data from electrocardiography, echocardiography, and coronary angiography were diligently collected.
Echocardiography was conducted using an available digital ultrasound system by two cardiologists who were unaware of the clinical data. Measurements, including M mode, standard two-dimensional (2D), and pulsed Doppler, were carried out by the guidelines set by the American Society of Echocardiography. Cardiac dimensions were determined using the average of three cardiac cycles. Parameters such as LV ejection fraction, septal and left posterior wall thickness, left atrium diameter, LV end-systolic diameter, LV end-diastolic diameter, and LV outflow tract gradient were assessed.
Coronary angiography was performed at the operators' discretion, capturing multiple views at either 15 or 30 frames per second. caIMR was determined using the Flash Angio system, consisting of the Flash Angio console, Flash Angio software, and Flash Pressure transducer from Rainmed Ltd., Suzhou, China. A validated protocol utilizing computational pressure-flow dynamics (CPFD) was applied for caIMR estimation in three sequential steps. Initially, a simulated three-dimensional reconstruction of coronary arteries was generated for the targeted vessels. Subsequently, angio-Fractional Flow Reserve (angio-FFR) was estimated using CPFD, incorporating the estimated hyperemic aortic pressure (P'a) based on mean aortic pressure. The calculation of caIMR was then performed using the provided equation:
In this context, (Pd)hyp represents the mean pressure at the distal position during maximal hyperemia, with L denoting a constant representing the length from the inlet to the distal position. The constant K is assigned a value of 2.1, and Vdiastole stands for the mean flow velocity at the distal position during diastole. Additionally, Vhyp is calculated as K multiplied by Vdiastole, signifying the mean flow velocity at the distal position during maximal hyperemia.
caIMR was assessed in at least one of the three coronary arteries for all patients in our study. The epicardial vessel exhibiting the highest caIMR value among the three major coronary vessels was chosen for analysis. In the present study, CMD was identified based on caIMR>25U, consistent with observations from prior research Follow-up was conducted over a mean 43-month period through telephone contact or outpatient visits. The primary clinical endpoints in this study encompassed major adverse cardiac events (MACE), which included: 1) cardiac death: defined as events occurring in the context of cardiac decompensation, pulmonary edema, or progression to end-stage disease, along with other cardiac-related deaths; 2) non-cardiac death: defined as any death occurring during the follow-up period, irrespective of the cause; 3) cardiac readmissions: encompassing hospitalizations for heart failure, myocardial infarction, unstable angina, and malignant arrhythmias; and 4) ischemic stroke: denoting a stroke caused by a blockage in the blood flow to the brain.
- Being tested
- caIMR
- Keywords
- Hypertrophic cardiomyopathy, Coronary microvascular dysfunction., Index of microcirculatory resistance., Prognosis
- Medical subject headings
- Cardiomyopathy, Hypertrophic
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, and 460 coronary arteries were analyzed. CMD was identified with caIMR>25U, in line with prior research. Receives: Device: caIMR | |
| non-CMD | Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. 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)
The primary clinical endpoints in this study encompassed major adverse cardiac events (MACE), which included: 1) cardiac death: defined as events occurring in the context of cardiac decompensation, pulmonary edema, or progression to end-stage disease, along with other cardiac-related deaths; 2) non-cardiac death: defined as any death occurring during the follow-up period, irrespective of the cause; 3) cardiac readmissions: encompassing hospitalizations for heart failure, myocardial infarction, unstable angina, and malignant arrhythmias; and 4) ischemic stroke: denoting a stroke caused by a blockage in the blood flow to the brain.
Measured: Follow-up was conducted over a mean 43-month period through telephone contact or outpatient visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start13 Sep 2014
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Cicrovascular DysfunctionStudies 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
- 191 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
- NCT06190704
- Sponsor's protocol ID
- caIMR-HCM
- Acronym
- caIMR-HCM
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Coronary Microvascular Dysfunction Assessed by Microvascular Resistance in Hypertrophic Cardiomyopathy Patients
- ClinicalTrials.gov ID
- NCT06190704
- Acronym / sponsor ID
- caIMR-HCM / caIMR-HCM
- Keywords
- Hypertrophic cardiomyopathy, Coronary microvascular dysfunction., Index of microcirculatory resistance., Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Ya-Wei XuUniversity, hospital or other
- Study start
- 13 Sep 2014 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Jan 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.
The index of microcirculatory resistance (IMR) serves as an indicator of coronary microvascular dysfunction (CMD) with significant prognostic value in various clinical conditions. However, its impact on CMD in the hypertrophic cardiomyopathy (HCM), whether assessed invasively or non-invasively, is yet to be investigated. We assessed the prognostic importance of CMD using less invasive coronary angiography-derived IMR (caIMR) in HCM patients with nonobstructive epicardial coronary arteries.Patients with HCM who underwent invasive coronary angiography for suspected myocardial ischemia were included. Microvascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR>25U, in line with prior research, and the primary study endpoint was major adverse cardiac events (MACE).
Detailed description
Patients diagnosed with HCM and referred to the catheterization lab at Shanghai Tenth People's Hospital between 2014 and 2023 for invasive coronary angiography (CAG) due to suspected myocardial ischemia were included in this single-center retrospective observational study. The inclusion criteria of the present study were as follows: 1) Age >18 years old; 2) echocardiographic evidence of HCM, defined as LV myocardial wall thickness of ≥15 mm and or a LV myocardial wall thickness of ≥13 mm in individuals with a family history of HCM, in the absence of an alternative cause for LV hypertrophy. The exclusion criteria were: 1) significant mitral regurgitation; 2) second and third-degree atrioventricular block; 3) presence of significant epicardial coronary stenosis (≥50% stenosis) on CAG; 4) poor life expectancy resulting from concurrent health disease.; and 5) reduced contrast opacification (for caIMR assessment). Our study was conducted in accordance with the Helsinki Declaration and was approved by the ethical review board of Shanghai Tenth People's Hospital.
The essential clinical data, including age, gender, systolic and diastolic blood pressure, heart rate, as well as the past medical history encompassing diabetes, hypertension, hyperlipidemia, stroke, atrial fibrillation, heart failure, family history of HCM, syncope, and smoking history, were systematically recorded. Additionally, laboratory parameters such as total cholesterol, high- and low-density lipoprotein, triglycerides, and N-terminal pro-brain natriuretic peptide were documented. The cardiovascular medical medications, including beta-blockers, antiplatelet agents, ACE inhibitors/ARBs, calcium channel blockers, anticoagulants, diuretics, and amiodarone, for all participants were also noted. Data from electrocardiography, echocardiography, and coronary angiography were diligently collected.
Echocardiography was conducted using an available digital ultrasound system by two cardiologists who were unaware of the clinical data. Measurements, including M mode, standard two-dimensional (2D), and pulsed Doppler, were carried out by the guidelines set by the American Society of Echocardiography. Cardiac dimensions were determined using the average of three cardiac cycles. Parameters such as LV ejection fraction, septal and left posterior wall thickness, left atrium diameter, LV end-systolic diameter, LV end-diastolic diameter, and LV outflow tract gradient were assessed.
Coronary angiography was performed at the operators' discretion, capturing multiple views at either 15 or 30 frames per second. caIMR was determined using the Flash Angio system, consisting of the Flash Angio console, Flash Angio software, and Flash Pressure transducer from Rainmed Ltd., Suzhou, China. A validated protocol utilizing computational pressure-flow dynamics (CPFD) was applied for caIMR estimation in three sequential steps. Initially, a simulated three-dimensional reconstruction of coronary arteries was generated for the targeted vessels. Subsequently, angio-Fractional Flow Reserve (angio-FFR) was estimated using CPFD, incorporating the estimated hyperemic aortic pressure (P'a) based on mean aortic pressure. The calculation of caIMR was then performed using the provided equation:
In this context, (Pd)hyp represents the mean pressure at the distal position during maximal hyperemia, with L denoting a constant representing the length from the inlet to the distal position. The constant K is assigned a value of 2.1, and Vdiastole stands for the mean flow velocity at the distal position during diastole. Additionally, Vhyp is calculated as K multiplied by Vdiastole, signifying the mean flow velocity at the distal position during maximal hyperemia.
caIMR was assessed in at least one of the three coronary arteries for all patients in our study. The epicardial vessel exhibiting the highest caIMR value among the three major coronary vessels was chosen for analysis. In the present study, CMD was identified based on caIMR>25U, consistent with observations from prior research Follow-up was conducted over a mean 43-month period through telephone contact or outpatient visits. The primary clinical endpoints in this study encompassed major adverse cardiac events (MACE), which included: 1) cardiac death: defined as events occurring in the context of cardiac decompensation, pulmonary edema, or progression to end-stage disease, along with other cardiac-related deaths; 2) non-cardiac death: defined as any death occurring during the follow-up period, irrespective of the cause; 3) cardiac readmissions: encompassing hospitalizations for heart failure, myocardial infarction, unstable angina, and malignant arrhythmias; and 4) ischemic stroke: denoting a stroke caused by a blockage in the blood flow to the brain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMD | – | Device: caIMRMicrovascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR>25U, in line with prior research. |
| non-CMD | – | Device: caIMRMicrovascular function was assessed using caIMR, and 460 coronary arteries were analyzed. CMD was identified with caIMR≤25U, in line with prior research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HCM and referred to the catheterization lab at Shanghai Tenth People's Hospital between 2014 and 2023 for invasive coronary angiography (CAG) due to suspected myocardial ischemia were included in this single-center retrospective observational study
Key inclusion criteria (2 listed)
- Age >18 years old;
- echocardiographic evidence of HCM, defined as LV myocardial wall thickness of ≥15 mm and or a LV myocardial wall thickness of ≥13 mm in individuals with a family history of HCM, in the absence of an alternative cause for LV hypertrophy
Key exclusion criteria (5 listed)
- significant mitral regurgitation;
- second and third-degree atrioventricular block;
- presence of significant epicardial coronary stenosis (≥50% stenosis) on CAG;
- poor life expectancy resulting from concurrent health disease.;
- reduced contrast opacification (for caIMR assessment)
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 contact or outpatient visits.
The primary clinical endpoints in this study encompassed major adverse cardiac events (MACE), which included: 1) cardiac death: defined as events occurring in the context of cardiac decompensation, pulmonary edema, or progression to end-stage disease, along with other cardiac-related deaths; 2) non-cardiac death: defined as any death occurring during the follow-up period, irrespective of the cause; 3) cardiac readmissions: encompassing hospitalizations for heart failure, myocardial infarction, unstable angina, and malignant arrhythmias; and 4) ischemic stroke: denoting a stroke caused by a blockage in the blood flow to the brain.
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 8 Jan 2024.
- Individual participant dataSharing planned: No
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 Cicrovascular Dysfunction and Hypertrophic Cardiomyopathy Patients, 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 2 inclusion and 5 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 8 Jan 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 contact or outpatient visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2024.