The Platform for Interdisciplinary Cardiovascular-metabolic-neurovascular Diseases (PICMAN)

NCT06062836 | Unknown DMC

• 1 other identifier: PICMAN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background Changes in metabolism and mitochondrial function appear to precede cardiac dysfunction, with much evidence supporting metabolic dysregulation as one of the earliest precursors of cardiovascular disease. We hypothesise that quantifiable metabolic inflexibility may be representative of an individual in his/her silent, but high-risk progression towards insulin resistance, diabetes and cardiovascular disease. The platform for interdisciplinary cardiovascular-metabolic-neurovascular diseases (PICMAN) across National University Health System (NUHS) is a pilot, prospective, multi-ethnic cohort study in Singapore. Through extensive phenotyping in a preventive cardiology cohort, the central aim is to define the metabolic flexibility range in a cohort of individuals at elevated risk of atherosclerotic cardiovascular disease, to correlate metabolic flexibility to measures of cardiometabolic health, including diastolic dysfunction, coronary and cerebral atherosclerosis, body fat distribution and severity of non-alcoholic fatty liver disease.

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Metabolic flexibility

  Metabolic flexibility will be calculated (deltaRQ)

  Up to 5 years

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants between the ages of 21 and 70 at screening without a prior history of MACE, coronary artery disease diagnosis, established diabetes, with a calculated 10-year ASCVD risk \> 5% based on QRISK3 calculator are eligible for PICMAN. Recruitment of individuals takes place at NUHS, where community-dwelling individuals without cardiac disease will be referred via outreach to primary care and community partners in Singapore.

You may qualify if:

• Patients aged 21-70 at screening
• year ASCVD risk \> 5% measured by QRISK 3 calculator

You may not qualify if:

• Established DM (Prior diagnosis, long term medications or HbA1c \>=6.5)
• Established CVD, such as ischemic heart disease, cerebrovascular accident, heart failure, atrial fibrillation
• Pregnancy
• Known contraindications to CT scan, such as allergy to contrast

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Health System

Singapore, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Molecular phenotyping via 1. Analysis of peripheral blood mononuclear cells (PBMC) for immunometabolic profile analysis 2. Analysis of genomics and microbiome analysis using exosome isolates, stool and urine samples 3. "Omits" profiling covering their genomics, epigenomics, transcriptomics, and proteomics via differentiation of patient-derived iPSCs into cardiac cell-types

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mayank Dalakoti

  National University Health System

  PRINCIPAL INVESTIGATOR

• Roger Foo

  National University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayank Dalakoti

CONTACT

+6566011036; mayank_dalakoti@nuhs.edu.sg

Roger Foo

CONTACT

+6566011036; roger.foo@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: October 2, 2023
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-04

Locations

SG (1)