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New treatment option for Heart Disease
Official title Heart Disease of the Small Arteries in Women and Men
ClinicalTrials.gov ID: NCT00573027
What this study is testing
- What it's testing
- Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal...
- No obstructive coronary artery disease performed within the previous 24 months (\<50% luminal obstruction in one or more coronary arteries on...
- Age \> 18 years old
- Competent to give informed consent
You likely can't join if
- Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
- Prior non-cardiac illness with an estimated life expectancy \<4 years;
See the full eligibility criteria
- Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina...
- No obstructive coronary artery disease performed within the previous 24 months (\<50% luminal obstruction in one or more coronary arteries on angiography).
- Age \> 18 years old
- Competent to give informed consent
- Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
- Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
- Primary valvular heart disease clearly indicating the need for valve repair or replacement;
- Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
- Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
- Prior non-cardiac illness with an estimated life expectancy \<4 years;
- Unable to give informed consent;
- Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
- Contraindications to adenosine or Regadenoson (Lexiscan)
- Women and men with intermediate coronary stenoses (\>20% but \<50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgment of the...
- Heart failure (NYHA Class III or IV on treatment)
- LV dysfunction (ejection fraction \<40%)
- Documented obstructive myocardiopathy
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.