TerminatedNot Applicable

Measurements to Assess Severity of Epicardial Stenoses

Stopped: IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.

United States10 participantsStarted 2009-12

Plain-language summary

Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Abnormal Myocardial stress perfusion (SPECT) LV EF \> 25% * 18 years of age or above * Patients referred to a stress test by a Cardiologist * Acute Chest pain, as per patient input. * Risk Assessment with prior test results and/or previous history of known chronic stable CAD. * Borderline or discordant stress testing where obstructive CAD remains a concern. * New or worsening symptoms- Abnormal coronary angiography or abnormal prior stress imaging study. * Coronary stenosis or anatomic abnormality of uncertain significance. * In absence of reliable diagnostic information from another imaging modality. Exclusion Criteria: * Serum Creatinine \> 2.5 gm/dL * Type II HIT * Left ventricular ejection fraction less the 25% determined by gated SPECT imaging ( - LV \< or + to 25%) * Non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dL. * History of type II heparin-induced thrombocytopenia. * Significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated. * Pregnant women. * Incapacitated for Consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements

Timeframe: Upon Diagnostic Angiogram and Flow Wire

Trial details

NCT IDNCT00760630

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-02-24

View on ClinicalTrials.gov More Coronary Artery Disease trials