Risk Stratification Using PET in HCM (HCM-PET)

September 7, 2017 updated by: Region Gävleborg

Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)

The overall rationale is to reduce the risk of sudden cardiac death in individuals with hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable cardioverter defibrillator (ICD). This could potentially lead to an improved risk stratification of HCM patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Positron Emission Tomography (PET) is a functional imaging technique that utilizes radioactive tracers to gain information on physiological or pathophysiological processes in vivo. Different tracers can provide information on different processes of interest. In cardiology, metabolic processes consuming oxygen (aerobic) can be studied with 11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as left ventricular mass, left ventricular volumes and wall thickness can also be calculated with PET.

The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to improve risk stratification in HCM.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)

Description

Inclusion Criteria:

  • Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

Exclusion Criteria:

  • Patients younger than 18 years, pregnancy, breast feeding, claustrophobia, intolerance/allergic reaction to adenosin or mannitol, severe hypotension, unstable angina pectoris, incompensated systolic heart failure, increased intracranial pressure, hypovolemia, dipyramidole.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventricular tachycardia (VT) vs myocardial blood flow
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs ejection fraction
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs mass
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter mass
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs wall thickness
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter wall thickness
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs oxygen consumption
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs sympathetic innervation
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs myocardial external efficiency
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)
History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia (VT) vs stroke work
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)
History of VT since receiving an implantable defibrillator within last 15 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atrial fibrillation (AF) vs myocardial blood flow
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs ejection fraction
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs mass
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter mass
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs wall thickness
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter wall thickness
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs oxygen consumption
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs sympathetic innervation
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs myocardial external efficiency
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)
History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation (AF) vs stroke work
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)
History of VT since receiving an implantable defibrillator within last 15 years
Atrial size vs ventricular tachycardia
Time Frame: History of VT since receiving an implantable defibrillator within last 15 years
atrial diameter, volume vs ventricular tachycardia
History of VT since receiving an implantable defibrillator within last 15 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Gävleborg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dalarna County Council, Sweden
Uppsala University Hospital
Landstinget i Värmland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens Sörensen, MD PhD, Region Gävleborg

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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