Evaluating coronary blood flow and resistance in patients with angina
A Study of Pressure Waveform Analysis in Coronary Artery-II
This study is testing if using a special medication during heart tests can help people with angina understand their heart's blood flow and resistance better, while also checking how well these tests predict future heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Hsin-Chu Branch Academic / other |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT05672706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using intracoronary adenosine during evaluations of coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) in patients experiencing angina. It will measure the repeatability of CFR and IMR assessments while hyperemia is induced by adenosine and evaluate the correlation between coronary waveform signals and physiological ischemia as defined by fractional flow reserve (FFR) and CFR. Participants will undergo these assessments in a catheterization laboratory, followed by a three-year clinical event follow-up to determine the predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with angina who are undergoing evaluation for ischemic heart disease.
Not a fit: Patients with severe valvular heart disease, a history of asthma, or those with significantly low heart rates or blood pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of coronary blood flow dynamics and enhance risk stratification for patients with ischemic heart disease.
How similar studies have performed: While this approach is observational and builds on existing methodologies, similar studies have shown promise in assessing coronary flow dynamics, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with angina Exclusion Criteria: * Severe valvular heart disease * History of asthma * Heart rate less than 50 beats per minute * systolic blood pressure less than 90 mmHg
Where this trial is running
Hsinchu
- National Taiwan University Hospital Hsin-Chu branch — Hsinchu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chien-Boon Jong, MD
- Email: jgboon0407@gmail.com
- Phone: 035322140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.