Hypertrophic CardiomyopathyNCT06434415
Prognostic Value of Angio-IMR in Hypertrophic Cardiomyopathy Patients
An observational study of Hypertrophic Cardiomyopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jul 2024
- 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: We retrospectively enrolled patients who were diagnosed with hypertrophic cardiomyopathy(HCM) and underwent invasive coronary angiography between 2017 and 2024 at two sites (The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Ningbo Medical Center Lihuili Hospital, Ningbo, China) .The diagnosis of HCM was based on current clinical guidelines.
Who may be able to join
- diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
- have qualified image for analysis of angio-IMR
Who cannot join
- 1）referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest; 2) Implantation of any DES or DCB; 3）severe valve dysfunction; 4）history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5）meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 6）impaired life-span expectancy due to cancer or other clinical conditions；
About this study
Official title: Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients
Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.
Read the detailed description
Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. In this study, patients who met the inclusion criteria were collected from two centers, and the angio-IMR of three coronary arteries was measured to monitor their microcirculation. Then, explore the prognostic value of the angio-IMR of the left anterior descending artery (LAD). At the same time combined with the sum of three coronary arteries' angio-IMR, analysis of its prognostic value. In conclusion, this study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.
- Conditions
- Hypertrophic Cardiomyopathy
- 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 |
|---|---|---|
| HCM patients with low angio-IMR | This group patients have low angio-IMR value in LAD. | |
| HCM patients with high angio-IMR | This group patients have high angio-IMR value in LAD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE composite
a composition of death from cardiovascular causes, progression to severe functional limitation (NYHA class III or IV), and sustained, life-threatening ventricular arrhythmias requiring the implantation of a cardioverter-defibrillator,septal myocardial ablation or septal myectomy, new on stroke.
Measured: within 24 months' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jan 2017
- Primary completion31 Jan 2024
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital
- Responsible party
- Sponsor
- Investigators
- Jun Jiang, MD, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434415
- Sponsor's protocol ID
- 2024005
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients
- ClinicalTrials.gov ID
- NCT06434415
- Acronym / sponsor ID
- 2024005
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 30 May 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.
Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.
Detailed description
Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. In this study, patients who met the inclusion criteria were collected from two centers, and the angio-IMR of three coronary arteries was measured to monitor their microcirculation. Then, explore the prognostic value of the angio-IMR of the left anterior descending artery (LAD). At the same time combined with the sum of three coronary arteries' angio-IMR, analysis of its prognostic value. In conclusion, this study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCM patients with low angio-IMR | – | –This group patients have low angio-IMR value in LAD. |
| HCM patients with high angio-IMR | – | –This group patients have high angio-IMR value in LAD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively enrolled patients who were diagnosed with hypertrophic cardiomyopathy(HCM) and underwent invasive coronary angiography between 2017 and 2024 at two sites (The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China; Ningbo Medical Center Lihuili Hospital, Ningbo, China) .The diagnosis of HCM was based on current clinical guidelines.
Key inclusion criteria (2 listed)
- diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
- have qualified image for analysis of angio-IMR
Key exclusion criteria (1 listed)
- 1）referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest; 2) Implantation of any DES or DCB; 3）severe valve dysfunction; 4）history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 5）meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation; 6）impaired life-span expectancy due to cancer or other clinical conditions；
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
MACE composite
Time frame: within 24 months' follow-up
a composition of death from cardiovascular causes, progression to severe functional limitation (NYHA class III or IV), and sustained, life-threatening ventricular arrhythmias requiring the implantation of a cardioverter-defibrillator,septal myocardial ablation or septal myectomy, new on stroke.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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.
Jun Jiang, MD, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
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?
MACE composite (time frame: within 24 months' follow-up). 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 1 Aug 2024.