Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT (METS)

February 22, 2019 updated by: Hospital Universitari Vall d'Hebron Research Institute
The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT (Single Photon Emission Computed Tomography) are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to analyze metabolomic pattern of patients after cardiac stress in order to detect differences based on the type of stress (physical or pharmacological with adenosine agonists) and result of test (positive or negative for ischemia) and to indentify biochemical markers with prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors, pretest probability and previous cardiovascular disease will be recorded. Follow up will be at one, three and five years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients undergoing myocardial perfusion SPECT are taken before, immediately after stress and 2h after stress. Serum samples will be analyzed by nuclear magnetic resonance in order to know metabolomic profile.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with prescription of cardiac perfusion SPECT

Description

Inclusion Criteria:

  • Patients men or women ≥ 18 years of age
  • Patients with prescription of cardiac perfusion SPECT

Exclusion Criteria:

  • Patients with loss of consciousness or confuse, not able to read the information and to sign the writting consent
  • Pregnant women
  • Patients with dobutamine indications in the stress protocol

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-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Physical Cardiac Stress
Other: Non intervention
Patients with Physical and Pharmacological Cardiac Stress
Patients with Physical and Pharmacological Cardiac Stress with adenosine agonist
Other: Non intervention
Patients with Pharmacological Cardiac Stress
Patients with Pharmacological Cardiac Stress with adenosine agonist
Other: Non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.
Time Frame: 2 days
2 days
Metabolomic profile on NMR (Nuclear Magnetic Resonance ) analysis of serum sample
Time Frame: 6 month
Once all samples analyzed, in order to identify of specific patterns associated to any group (type of test or result of test).
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time Frame: 1 year
1 year
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time Frame: 3 years
3 years
Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.
Time Frame: 5 years
5 years
Angina treatment initiation
Time Frame: 1 year
1 year
Angina treatment initiation
Time Frame: 3 years
3 years
Angina treatment initiation
Time Frame: 5 years
5 years
Metabolomic profile on NMR analysis of serum sample
Time Frame: 1 year
1 year
Metabolomic profile on NMR analysis of serum sample
Time Frame: 3 years
3 years
Metabolomic profile on NMR analysis of serum sample
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

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, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METS

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

product manufactured in and exported from the U.S.

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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