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Clinical Trials/NCT02968771
NCT02968771UnknownNot Applicable

Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country500 target enrollmentStarted: November 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
500
Locations
1
Primary Endpoint
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.

Time Frame: 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).

Secondary Outcomes

  • Combined end point: Cardiovascular death, Myocardial infarction, Coronary revascularization.(5 years)
  • Metabolomic profile on NMR analysis of serum sample(5 years)
  • Angina treatment initiation(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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