MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR) (CHOLCOEUR)

August 4, 2015 updated by: Institute of Cardiometabolism and Nutrition, France

MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA

Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from silent micro-infarctions (MI) before clinical coronary heart disease manifestations because of the lifetime exposure to elevated serum LDL-cholesterol levels.

The study aims to demonstrate the higher prevalence of silent myocardial infarction in a population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular risk in comparison to control patients using Cardiac Magnetic Resonance sequences of delayed gadolinium enhancement.

Study Overview

Status

Unknown

Conditions

Detailed Description

To demonstrate the higher prevalence of silent myocardial infarction in a population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular risk in comparison to control patients, the protocol is the following:

  • to enroll 75 patients with familial hypercholesterolemia (FH)
  • to enroll 35 subjects without FH (control group)
  • for each subject, to collect data from his medical file (blood test results) and to perform a cardiac and aortic MRI in order to evaluate the micro-infarction proportion.

The study will be performed according to GCPs and with respect with french laws.

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Unité de prévention des maladies cardiovasculaires- Unité INSERM 939 Pôle Cardiologie/Métabolisme Groupe Hospitalier Pitié-Salpêtrière
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

110 subjects divided into:

  • 75 patients with heterozygous form at high cardiovascular risk
  • 35 controls patients without dyslipidaemia

Description

Inclusion criteria:

For patients with heterozygous form of familial hypercholesterolemia:

  • Aged between 40 and 60 years
  • With an identified genetic mutation (LDL-R, ApoB, PCSK9)
  • Asymptomatic,
  • With no EKG sign of ischemia
  • No personal history of coronary heart disease.
  • Treated or untreated by lipid lowering treatment

  • High cardiovascular risk identified by 1 of the following criteria:

    1. Current smoking (1 cigarette a day) 2 Family history of very premature onset CHD: first- or second-degree male relative onset before age 45, first- or second-degree female relative onset before age 55 3.Two or more cardiovascular risk factors among this list: increasing age (men > 30, women > 40 years of age), LDL-C > 250 mg/dL, male sex, family history of premature onset CHD, first-degree male relative onset before age 55, first-degree female relative onset before age 65, metabolic syndrome, HDL-C < 40 mg/dL, hypertension (BP > 140/or > 90 mmHg or drug treatment), Lp (a) ≥ 50 mg/dL, tendon xanthoma

For control subjects:

  • Aged between 40 and 60 years
  • With a normal lipid profile (LDL-C < 1.6g/L HDL-C > 0,45g/L and TG < 4g/L) and untreated by any lipid lowering therapies
  • Asymptomatic,
  • With EKG showing normal sinus rhythm , no sign of ischemia nor Left Bundle Branch Block
  • No personal history of coronary heart disease.
  • Control subjects will be matched for age/gender/smoking status and blood pressure

Exclusion criteria:

  • Non-affiliation to a healthcare system
  • Consent refusal
  • Contra-indication to MRI or to gadolinium injection.
  • Claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, pregnancy, nursing
  • Renal failure
  • Technical contra-indication: patient diameter > 70 cm weight > 250 kg
  • Personal history of cardiovascular disease and myocardial infarction
  • Diabetes mellitus
  • Uncontrolled hypertension
  • TG < 4 g/L
  • Previous use of an Amgen product in the past 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Familial hypercholesterolemia patients
  • clinical data
  • biological data
  • cardiac and aortic RMI with gadolinium
Control group
  • clinical data
  • biological data
  • cardiac and aortic RMI with gadolinium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients presenting with at least one micro infarction at RMI
Time Frame: Within 4 weeks after consent signature
Cardiac and aortic RMI with gadolinium
Within 4 weeks after consent signature

Secondary Outcome Measures

Outcome Measure
Time Frame
LDL-Cholesterol burden (compared to standard values)
Time Frame: The most recent value within the last 5 years.
The most recent value within the last 5 years.
Anatomic and functional indexes of the aorta (maximal and minimal areas of aortic lumen, aortic flow)
Time Frame: Within 4 weeks after consent signature
Within 4 weeks after consent signature
Correlations between LDL-Cholesterol burden & presence of micro infarction, between LDL-Cholesterol burden & myocardial fibrosis, and between LDL-Cholesterol burden & aortic stiffness indexes
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiometabolism and Nutrition, France

Collaborators

Amgen

Investigators

  • Principal Investigator: David Rosenbaum, MD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14DRM_CHOLCOEUR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Familial Hypercholesterolemia - Heterozygous

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe