Myocardial Ischemia Without Obstructive Coronary Stenoses

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital San Carlos, Madrid

About this trial

Coronary-related myocardial ischemia can result from obstructive epicardial stenosis or non-obstructive causes including coronary microcirculatory dysfunction and vasomotor disorders. This prospective study has been created in order to provide knowledge in the field of non-obstructive coronary artery disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent available.

Age ≥ 18 years.

Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.

Disqualifiers

Hemodynamic instability.

Anticipated technical issues for physiology wire measurements.

Culprit vessel of acute coronary syndrome

Contraindications for adenosine administration.

Trial population

The target population consists of patients with clinically indicated invasive physiological measures of coronary pressure and flow with adenosine and acetylcholine for the assessment of myocardial ischemia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment

    Diagnostic test

    Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Myocardial ischemia without obstructive coronary stenosis1 intervention

Trial outcomes

Primary outcomes

1

Patient-oriented composite outcome

Incidence of a patient-oriented composite outcome, a composite of any death, nonfatal myocardial infarction, any ischemia-driven revascularization or hospitalization due to unstable angina pectoris

Time frame
Up to 5 years
2

Vessel-oriented composite outcome

Incidence of a vessel-oriented composite outcome, a composite of cardiac death, target-vessel related myocardial infarction or target-vessel revascularization

Time frame
Up to 5 years
3

Patient symptoms burden

Change in the Seattle questionnaire of angina scoring, associated to stratified medical treatment. Minimum is 0 and maximum is 100 and lower scores indicate worse outcome

Time frame
Up to 12 months

Secondary outcomes

1

Cumulative incidence of any death

Time frame
Up to 5 years
2

Cumulative incidence of cardiac death

Time frame
Up to 5 years
3

Cumulative incidence of nonfatal myocardial infarction

Time frame
Up to 5 years
4

Cumulative incidence of ischemia-driven revascularization

Time frame
Up to 5 years

Other outcomes

1

Resting and hyperemic mean aortic pressure (mmHg)

Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test

Time frame
During procedure
2

Resting and hyperemic mean intracoronary distal pressure (mmHg)

Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

Time frame
During procedure
3

Resting and hyperemic mean coronary flow (mean transit time or cms/sec)

Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

Time frame
During procedure
4

Resting and hyperemic coronary microcirculatory resistance (units)

Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

Time frame
During procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital San Carlos, Madrid

Lead sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Collaborator