Angina Pectoris Clinical Trial
— MVP-ANOCAOfficial title:
A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
The goal of this clinical trial is to learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing. Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 50 days. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study. Specific inclusion criteria for randomization: - Absence of significant epicardial coronary artery disease on angiography - Fractional flow reserve > 0.80 And = 1 of the following: - Epicardial coronary spasm on acetylcholine testing - Microvascular spasm on acetylcholine testing - Coronary flow reserve < 2.0 - Index of microcirculatory resistance = 25 - Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio = 0.76 Exclusion Criteria: - Acute coronary syndrome less than one week prior to enrolment - Cardiomyopathy - Contraindications to beta-blockers or calcium channel blockers - Baseline systolic blood pressure < 95 mmHg - Baseline heart rate < 55 bpm |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Hospital | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seattle Angina Questionnaire summary score | Change in Seattle Angina Questionnaire summary score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | EuroQol 5 dimension - 5L index score | Change in EuroQol 5 dimension score - 5L index score at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | EuroQol 5 dimension - 5L visual analogue score | Change in EuroQol 5 dimension score - 5L visual analogue score at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | PHQ-4 score | Change in PHQ-4 at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. | 7 weeks | |
Secondary | Treatment Satisfaction Questionnaire for Medication score | Change in Treatment Satisfaction Questionnaire for Medication score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes | Change in Seattle Angina Questionnaire summary score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes | EuroQol 5 dimension - 5L index score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes | EuroQol 5 dimensions - 5L visual analogue score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | PHQ-4 scores stratified by specific chest pain endotypes | PHQ-4 score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome. | 7 weeks | |
Secondary | Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes | Treatment Satisfaction Questionnaire for Medication scores at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | Seattle Angina Questionnaire summary score stratified by baseline angina frequency | Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome. | 7 weeks | |
Secondary | Proportion of patients with good response, no angina, and excellent health status | Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score = 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score = 75). | 7 weeks | |
Secondary | Safety endpoints | Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure | Baseline | |
Secondary | Major adverse cardiac events | Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina. | 7 weeks |
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