## Protocol Section
### Identification Module
**NCT ID:** NCT06413160

**Acronym:** JoCRMSSurvey

**Brief Title:** The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan

**Official Title:** The Cardiovascular-Renal-Metabolic (CRM) Syndrome Survey in Jordan

#### Organization Study ID Info
**ID:** CVA/JoCRM-2/2024
#### Organization
**Class:** OTHER
**Full Name:** Jordan Collaborating Cardiology Group
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Cardiovascular Academy

**Class:** UNKNOWN

**Name:** The Association of Jordanian Medical Laboratory Specialists AJMLS

#### Lead Sponsor

**Class:** OTHER

**Name:** Jordan Collaborating Cardiology Group

#### Responsible Party

**Investigator Affiliation:** Jordan Collaborating Cardiology Group

**Investigator Full Name:** Ayman J Hammoudeh, MD, FACC

**Investigator Title:** Director, Department of Clinical Research

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual. Surveying this syndrome in a large population in Jordan aims at studying the risk factors, components and stages of the syndrome, thus helping early screening, diagnosing and treating disease and its risk factors.

**Detailed Description:** Cardiovascular-renal-metabolic (CRM) syndrome is defined as a systemic disorder with a collection of related signs and symptoms attributable to the coexistence of multiple cardiovascular, renal and metabolic disease with a common underlying pathophysiology in one individual.

CRM syndrome reflects the intersection of cardiovascular disease with chronic kidney disease (CKD), and metabolic disease and risk factors (RF). A critical combination of these diseases and their risk factors in the same individual has a profound impact on quality of life and overall mortality. The clinical implications of the presence of CRM are significant, with premature morbidity and mortality, multiple organ-system disease, and high health care budgets mainly driven by the burden of cardiovascular disease (CVD).

There are high prevalence rates of all components of CRM and its RF on a global level and in the Middle East. Of note is the high prevalence of CV in the young, smoking, diabetes mellitus, obesity and dyslipidemia.

The current study will evaluate the prevalence of components and RF of CRM disease in a large population in North, central and South of Jordan.

In the Middle East, no systematic study has evaluated the definition of CRM, definition of its stages, and prevalence of its RF and its relation to the coexisting social determinants of health.

The study will provide new and contemporary knowledge on the definition, staging, and comprehensive approaches to care for patients with CRM, and subsequently exploring opportunities for prevention and care optimization by life style modification and pharmacotherapy.

There are different aspects that explain the interaction between the components of CRM. (A) The bidirectional association between the heart failure and the kidneys (cardiorenal syndrome) in addition to the risk of CAD in patients with CKD, (B) adipose tissue link to atherosclerosis mediated by inflammation, insulin resistance and endothelial dysfunction, and risk for DM (C) DM link to CVD, heart failure and kidney dysfunction., and many other links as well.

Screening for CRM is an important pillar in promoting health in every community. The CRM staging system facilitates identifying individuals at progressive levels of severity starting from the preclinical phase to delay or avoid the onset of clinical CVD and CKD. To appropriately find individuals at stage 0 (i.e., asymptomatic stage) it is important to undertake active screening within the population.

### Conditions Module

**Conditions:**

- Cardiovascular-renal-metabolic Syndrome

### Design Module

#### Bio Spec

**Description:** Centrifuged plasma obtained from peripheral blood sample of the participants

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 1. CVD A. Coronary heart disease: Silent and clinical CAD (chronic stable coronary disease, acute coronary disease \[ST-elevation myocardial infarction and non-ST-elevation acute coronary syndrome\].

   B. Heart failure. C. Atrial fibrillation. D. Stroke. E. Peripheral artery disease
2. Renal: chronic kidney disease
3. Metabolic:

A. Obesity/ B. Diabetes mellitus (DM).

**Measure:** Prevalence of cardiovascular-renal-metabolic syndrome

**Time Frame:** From date of study entry through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** Elevated level of lipoprotein (a) , homocysteine, high sensitivity C-Reactive Protein, insulin resistance, and Urine Creatinine/Albumin ratio.

**Measure:** Elevated levels of blood markers

**Time Frame:** From date of study entry through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults (age 18 years and above).
* Willing to sign an informed consent.

Exclusion Criteria:

* None.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Consecutive individuals (N=10,000) visiting allocated medical laboratories in North, Center, and South sections of the country during public free blood testing campaigns planned in August 2024 to June 2025.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hammoudeh_ayman@yahoo.com

**Name:** Ayman Hammoudeh, MD, FACC

**Phone:** 065001000

**Role:** CONTACT

**Contact 2:**

**Email:** alhaddad63@gmail.com

**Name:** Imad A Alhaddad, MD, FACC

**Phone:** 065608080

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Amman

**Contacts:**

***Contact 1:***

- **Email:** hammoudeh_ayman@yahoo.com

- **Name:** Ayman Hammoudeh, MD FACC

- **Phone:** 065001000

- **Role:** CONTACT

**Country:** Jordan

**Facility:** Istishari Hospital

**Zip:** 11184

#### Overall Officials

**Official 1:**

**Affiliation:** Istisjhari Hospital

**Name:** Ayman Hammoudeh, MD, FACC

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Jordan Hospital

**Name:** Imad A Alhaddad, MD, FACC

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000024821

- Term: Metabolic Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
