Microvascular DysfunctionNCT05671367
Association Between Microvascular Resistance and Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy
An observational study of Microvascular Dysfunction and Hypertrophic Obstructive Cardiomyopathy, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction. Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy. This new measurement method is microcirculation resistance (MR) based on quantitative flow ratio (QFR), which does not need a pressure guide… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy, Microcirculation Resistance
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Nov 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2017 to November 2021, patients with hypertrophic obstructive cardiomyopathy underwent coronary angiography in Fuwai Hospital.
Who may be able to join
- Aged 18-80 years old;
- Patients with hypertrophic obstructive cardiomyopathy undergoing coronary angiography. Diagnosis criteria that meet the diagnostic guidelines for hypertrophic obstructive cardiomyopathy: It usually refers to the thickness of the ventricular septum or left ventricular wall measured by two-dimensional echocardiography > 15 mm, or the thickness of > 13mm in patients with a clear family history, usually without enlargement of the left ventricular cavity, and the thickening of the left ventricular wall caused by increased loads, such as hypertension, aortic stenosis, and congenital subvalvular septum should be excluded; LVOTG>30 mmHg under quiet or exercise conditions.
- The informed consent form for the use of sample data of patients admitted to the hospital has been signed;
Who cannot join
- No contrast examination is performed for various reasons;
- Missing baseline important information indicators;
- Loss of follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, China National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
Official title: Evaluation of the Correlation Between Coronary Microvascular Resistance Based on Quantitative Flow Ratio and Major Adverse Cardiovascular Events in Patients With Obstructive Hypertrophic Cardiomyopathy: A Retrospective Cohort Study
About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction. Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy. This new measurement method is microcirculation resistance (MR) based on quantitative flow ratio (QFR), which does not need a pressure guide wire on the basis of angiography. The QFR system is used to evaluate the blood vessels distal pressure and blood flow, and their ratio is microcirculation resistance (MR). The quantitative blood flow fraction measurement system was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). This study is a single-center retrospective cohort study. Participants were selected from patients who were diagnosed with hypertrophic obstructive cardiomyopathy in Fuwai Hospital from January 2020 to November 2021. The risk factor is whether there is microcirculation resistance disorder. The outcome was the major adverse cardiovascular events related to HCM (including all-cause death, heart transplantation, left ventricular pacemaker, and heart failure readmission) that were followed up one year after angiography. Aim To further clarify whether there is a certain correlation between microvascular resistance and adverse cardiovascular prognosis.
- Conditions
- Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy, Microcirculation Resistance
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Artery without microcirculation resistance | The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR<2.5 mmHg*s/cm is defined as no microvascular resistance. | |
| Single artery with microcirculation resistance | The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. There is only one of three major coronary arteries in 3 that meets this condition. | |
| Multiple arteries with microcirculation resistance | The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. Two of the three major coronary arteries meet this condition. | |
| Three arteries with microcirculation resistance | The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. All three major coronary arteries meet this condition. | |
| Significant microcirculation resistance | The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. The sum of AMR of the three main arteries is greater than 7.5mmHg*s/cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Major Adverse Cardiovascular Events related to HoCM
including all-cause death, heart transplantation, left ventricular pacemaker, heart failure readmission
Measured: One-year followed up after angiography
Secondary outcomes (2)
Scale of KCCQ-12
KCCQ-12, a questionnaire of cardiomyopathy in Kansas City, which comes from the telephone follow-up or reexamination of cardiac rehabilitation records of departments, consists of 8 questions and 12 items, which are simplified from KCCQ-23. The score ranged from 0 to 100 points, with a higher score and better health.
Measured: One-year followed up after angiography
Borg Index after 6MWT
Borg index reflects the dyspnea and fatigue level after 6MWT, with a standard score of 0-10. The score ranged from 0 to 10 points, and a higher score indicated a better prognosis.
Measured: One-year followed up after angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2017
- Primary completion1 Nov 2021
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Microvascular DysfunctionStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- 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
- 340 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lihong Ma, China National Center for Cardiovascular Diseases
- Investigators
- Lihong Ma, MD, Principal investigator, Fuwai Hospital, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671367
- Sponsor's protocol ID
- 2022-1872
- Status last verified
- Jan 2023
- First submitted
- 31 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
PubMed 25173338Maron BJ, Maron MS. Hypertrophic cardiomyopathy. Lancet. 2013 Jan 19;381(9862):242-55. doi: 10.1016/S0140-6736(12)60397-3. Epub 2012 Aug 6.
PubMed 22874472Stahli BE, Erbay A, Steiner J, Klotsche J, Mochmann HC, Skurk C, Lauten A, Landmesser U, Leistner DM. Comparison of resting distal to aortic coronary pressure with angiography-based quantitative flow ratio. Int J Cardiol. 2019 Mar 15;279:12-17. doi: 10.1016/j.ijcard.2018.11.093. Epub 2018 Nov 17.
PubMed 30545620Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.
PubMed 29449274Fan Y, Fezzi S, Sun P, Ding N, Li X, Hu X, Wang S, Wijns W, Lu Z, Tu S. In Vivo Validation of a Novel Computational Approach to Assess Microcirculatory Resistance Based on a Single Angiographic View. J Pers Med. 2022 Oct 31;12(11):1798. doi: 10.3390/jpm12111798.
PubMed 36573725
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correlation Between Coronary Microvascular Resistance Based on Quantitative Flow Ratio and Major Adverse Cardiovascular Events in Patients With Obstructive Hypertrophic Cardiomyopathy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05671367
- Acronym / sponsor ID
- 2022-1872
- Conditions
- Microvascular Dysfunction, Hypertrophic Obstructive Cardiomyopathy, Microcirculation Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Jan 2023 (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.
About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction. Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy. This new measurement method is microcirculation resistance (MR) based on quantitative flow ratio (QFR), which does not need a pressure guide wire on the basis of angiography. The QFR system is used to evaluate the blood vessels distal pressure and blood flow, and their ratio is microcirculation resistance (MR). The quantitative blood flow fraction measurement system was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). This study is a single-center retrospective cohort study. Participants were selected from patients who were diagnosed with hypertrophic obstructive cardiomyopathy in Fuwai Hospital from January 2020 to November 2021. The risk factor is whether there is microcirculation resistance disorder. The outcome was the major adverse cardiovascular events related to HCM (including all-cause death, heart transplantation, left ventricular pacemaker, and heart failure readmission) that were followed up one year after angiography. Aim To further clarify whether there is a certain correlation between microvascular resistance and adverse cardiovascular prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Artery without microcirculation resistance | – | –The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR<2.5 mmHg*s/cm is defined as no microvascular resistance. |
| Single artery with microcirculation resistance | – | –The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. There is only one of three major coronary arteries in 3 that meets this condition. |
| Multiple arteries with microcirculation resistance | – | –The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. Two of the three major coronary arteries meet this condition. |
| Three arteries with microcirculation resistance | – | –The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. All three major coronary arteries meet this condition. |
| Significant microcirculation resistance | – | –The angiographic microvascular resistance (AMR) index was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0). AMR≥2.5 mmHg*s/cm is defined as microvascular resistance. The sum of AMR of the three main arteries is greater than 7.5mmHg*s/cm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2017 to November 2021, patients with hypertrophic obstructive cardiomyopathy underwent coronary angiography in Fuwai Hospital.
Key inclusion criteria (3 listed)
- Aged 18-80 years old;
- Patients with hypertrophic obstructive cardiomyopathy undergoing coronary angiography. Diagnosis criteria that meet the diagnostic guidelines for hypertrophic obstructive cardiomyopathy: It usually refers to the thickness of the ventricular septum or left ventricular wall measured by two-dimensional echocardiography > 15 mm, or the thickness of > 13mm in patients with a clear family history, usually without enlargement of the left ventricular cavity, and the thickening of the left ventricular wall caused by increased loads, such as hypertension, aortic stenosis, and congenital subvalvular septum should be excluded; LVOTG>30 mmHg under quiet or exercise conditions.
- The informed consent form for the use of sample data of patients admitted to the hospital has been signed;
Key exclusion criteria (3 listed)
- No contrast examination is performed for various reasons;
- Missing baseline important information indicators;
- Loss of follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Major Adverse Cardiovascular Events related to HoCM
Time frame: One-year followed up after angiography
including all-cause death, heart transplantation, left ventricular pacemaker, heart failure readmission
2 secondary outcomes
Scale of KCCQ-12
Time frame: One-year followed up after angiography
Borg Index after 6MWT
Time frame: One-year followed up after angiography
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 13 Jan 2023.
- Background: PubMed 25173338Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 22874472Maron BJ, Maron MS. Hypertrophic cardiomyopathy. Lancet. 2013 Jan 19;381(9862):242-55. doi: 10.1016/S0140-6736(12)60397-3. Epub 2012 Aug 6.
- Background: PubMed 30545620Stahli BE, Erbay A, Steiner J, Klotsche J, Mochmann HC, Skurk C, Lauten A, Landmesser U, Leistner DM. Comparison of resting distal to aortic coronary pressure with angiography-based quantitative flow ratio. Int J Cardiol. 2019 Mar 15;279:12-17. doi: 10.1016/j.ijcard.2018.11.093. Epub 2018 Nov 17.
- Background: PubMed 29449274Park J, Lee JM, Koo BK, Shin ES, Nam CW, Doh JH, Hwang D, Zhang J, Hu X, Wang J, Ye F, Chen S, Yang J, Chen J, Tanaka N, Yokoi H, Matsuo H, Takashima H, Shiono Y, Akasaka T. Clinical Relevance of Functionally Insignificant Moderate Coronary Artery Stenosis Assessed by 3-Vessel Fractional Flow Reserve Measurement. J Am Heart Assoc. 2018 Feb 15;7(4):e008055. doi: 10.1161/JAHA.117.008055.
- Background: PubMed 36573725Fan Y, Fezzi S, Sun P, Ding N, Li X, Hu X, Wang S, Wijns W, Lu Z, Tu S. In Vivo Validation of a Novel Computational Approach to Assess Microcirculatory Resistance Based on a Single Angiographic View. J Pers Med. 2022 Oct 31;12(11):1798. doi: 10.3390/jpm12111798.
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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.
Lihong Ma, MD principal investigator
Fuwai Hospital, China National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Dysfunction and Hypertrophic Obstructive Cardiomyopathy, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 3 inclusion and 3 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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The Major Adverse Cardiovascular Events related to HoCM (time frame: One-year followed up after angiography). 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 NCT05671367, which also lists 5 linked publications.
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 13 Jan 2023.