Evaluation of Patients With Non-obstructive Coronary Arteries

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStanford University

About this trial

Patients with angina and non-obstructive CAD are common within clinical practice, but remain a challenge with regard to diagnosis and treatment. When these patients undergo a comprehensive evaluation at the time of invasive coronary angiography, occult coronary abnormalities are frequently found. We hope to learn the overall prevalence and presentation of these occult coronary abnormalities and its long term outcome in this patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia.

Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month).

Disqualifiers

Asymptomatic (such as a pre-op cath)

Status-post heart transplant

Age <18

Renal insufficiency (creatinine >1.5)

Trial population

Adult women and men with angina who have been referred for an elective coronary angiogram because of a reasonable clinical suspicion of coronary ischemia.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 30 cc blood draw

    Procedure/Surgery
  • Intravascular ultrasound (IVUS)

    Procedure/Surgery
  • Coronary pressure/flow wire testing

    Procedure/Surgery
  • Coronary pressure/flow testing: Acetycholine challenge

    Procedure/Surgery
  • Procedure: Coronary pressure/flow testing: Nitroglycerin challenge

    Procedure/Surgery
  • Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge

    Procedure/Surgery

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque

This outcome is to measure the prevalence of angina and non-obstructive coronary arteries (ANOCA) endotypes

Time frame
Day of procedure (study day one)
2

Number of participants with major adverse cardiovascular events (MACE)

MACE - death, heart attack, revascularization, stroke

Time frame
15 years

Secondary outcomes

1

Change in Seattle angina questionnaire score

Scores range from 0 - 100, higher score means better outcome

Time frame
Baseline, 6 months, 1 year, 3 year, every 5 years thereafter
2

Number of patients with cardiovascular rehospitalization

Time frame
15 years

Other outcomes

Sponsors and contacts

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