Metabolomic Profile of Patients Undergoing Myocardial Perfusion SPECT

• Conditions: Ischemic Heart Disease
• Interventions: Other: Non intervention

• Registration Number: NCT02968771
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Physical Cardiac Stress	Non intervention	Patients with Physical Cardiac Stress
Patients with Physical and Pharmacological Cardiac Stress	Non intervention	Patients with Physical and Pharmacological Cardiac Stress with adenosine agonist
Patients with Pharmacological Cardiac Stress	Non intervention	Patients with Pharmacological Cardiac Stress with adenosine agonist

Primary Outcome Measures

Name	Time	Method
Result of myocardial perfusion SPECT: positive or negative for angina, ischemia or perfusion defect.	2 days
Metabolomic profile on NMR (Nuclear Magnetic Resonance ) analysis of serum sample	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain