Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

NCT ID: NCT02968771

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-06-30

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.

Conditions

Ischemic Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Physical Cardiac Stress

Patients with Physical Cardiac Stress

Non intervention

Intervention Type: OTHER

Patients with Physical and Pharmacological Cardiac Stress

Patients with Physical and Pharmacological Cardiac Stress with adenosine agonist

Non intervention

Intervention Type: OTHER

Patients with Pharmacological Cardiac Stress

Patients with Pharmacological Cardiac Stress with adenosine agonist

Non intervention

Intervention Type: OTHER

Interventions

Non intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

Spain

References

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Other Identifiers

METS

Identifier Type: -

Identifier Source: org_study_id