## Protocol Section
### Identification Module
**NCT ID:** NCT06434415

**Brief Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients

**Official Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients

#### Organization Study ID Info
**ID:** 2024005
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Hypertrophic Cardiomyopathy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 470

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** HCM patients with low IMR

#### Arm Group 2

**Label:** HCM patients with high IMR

### Outcomes Module

#### Primary Outcomes

**Description:** a composition of cardiac death, readmission for heart failure, and cardiac infraction

**Measure:** MACE composite

**Time Frame:** within 24 months' follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
2. have qualified image for analysis of angio-IMR

Exclusion Criteria:

1. referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest;
2. severe valve dysfunction;
3. history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation;
4. meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation;
5. impaired life-span expectancy due to cancer or other clinical conditions；

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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 the Second Affiliated Hospital of Zhejiang University School of Medicine.The diagnosis of HCM was based on current clinical guidelines.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Second affiliated Hospital Zhejiang University School of Medicine

**Name:** Jun Jiang, MD, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000001020

- Term: Aortic Stenosis, Subvalvular

- ID: D000001024

- Term: Aortic Valve Stenosis

- ID: D000082862

- Term: Aortic Valve Disease

- ID: D000006349

- Term: Heart Valve Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophic

- ID: M12154

- Name: Cardiomyopathies

- Relevance: HIGH

- As Found: Cardiomyopathy

- ID: M5568

- Name: Cardiomyopathy, Hypertrophic

- Relevance: HIGH

- As Found: Hypertrophic Cardiomyopathy

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M4340

- Name: Aortic Valve Stenosis

- Relevance: LOW

- As Found: Unknown

- ID: M2379

- Name: Aortic Valve Disease

- Relevance: LOW

- As Found: Unknown

- ID: M9437

- Name: Heart Valve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T449

- Name: Aortic Valve Stenosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009202

- Term: Cardiomyopathies

- ID: D000002312

- Term: Cardiomyopathy, Hypertrophic

- ID: D000006984

- Term: Hypertrophy

### Misc Info Module

- Version Holder: 2024-05-31
