Angina PectorisPhase 3NCT00000554
Women's Ischemia Syndrome Evaluation (WISE)
A Phase 3 study testing Angiography, MRI, Dobutamine-Stress Echocardiography, PET, and Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing in people with Angina Pectoris and Cardiovascular Diseases, run by University of Pittsburgh.
Trial summary
To evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease
- What is being tested?
- Angiography, MRI, Dobutamine-Stress Echocardiography, PET, and Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2001to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Women over the age of 18 who have suspected ischemic heart disease.
About this study
To evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Other objectives include developing safe, accurate, and cost effective diagnostic approaches for evaluating women with suspected ischemic heart disease, and determining the frequency of myocardial ischemia in the absence of significant epicardial coronary stenosis, as well as the frequency of non-ischemic or non-cardiac chest pain. A key aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in the absence of obstructive coronary disease.
Read the detailed description
BACKGROUND:
Cardiovascular disease exacts a heavy burden on the health of women. Ischemic heart disease claims the lives of nearly 250,000 women in the United States each year. Recognition of ischemic heart disease in women is a major challenge to the primary care physician. Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain, or events such as a myocardial infarction, which are evaluated by a physician who will confirm the diagnosis with objective tests. Unfortunately, both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women. Chest pain syndromes suspicious for myocardial ischemia are common in women. Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women. This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physician's decision to further evaluate women at risk. With precision in diagnosis, efforts to optimize therapies are hampered.
The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology. The utility of this approach is well established. However, although the presence of atherosclerosis is sufficient to cause myocardial ischemia, whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis, is not known and may be important for women.
Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits. Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction. The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis. Cycling hormones may further influence these complex interactions. Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or, for example, endothelial dysfunction which places the patient at risk for untoward coronary events.
The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in April 1994.
DESIGN NARRATIVE:
The Women's Ischemia Syndrome Evaluation (WISE) was a four center study designed to evaluate ischemic heart disease and its pathophysiology in women. WISE testing focused on three areas: 1) optimizing symptom evaluation and diagnostic testing for ischemic heart disease; 2) exploring mechanisms for symptoms and evidence of myocardial ischemia in the absence of epicardial coronary artery disease; 3) evaluating the influence of reproductive hormones on symptoms and diagnostic test response. The WISE core data base included demographic and clinical data, symptom and psychosocial variables, coronary angiography and ventriculography data, blood lipoprotein/homocysteine/lipid peroxidation/genetic/hormone/ phytoestrogen analysis, brachial artery reactivity testing, and resting/ambulatory electrocardiographic (ECG) monitoring. Site specific complementary methods included physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism, ventriculography, endothelial vascular function and coronary angiography. Women were followed for at least one year to assess clinical events and symptom status. In the Phase I (1996-7), a pilot phase, 256 women were studied. Phase II has completed enrolling 1008 women in the study. The WISE study defined contemporary and comprehensive state-of-the-art diagnostic testing to evaluate women with suspected ischemic heart disease, and explore sex specific ischemic heart disease pathophysiology.
The study has been renewed through April, 2005 to extend patient follow-up for a minimum of five years. Dr. Kelsey (U01HL64829) of the Data Coordinating Center at the University of Pittsburgh will continue the follow-up, develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables, assess cost effectiveness of the WISE testing techniques, and continue data analyses. Dr. Reis (U01HL64914) will study the immunologic basis of coronary disease in women, focusing on the role of inflammation and cytokine production. He will measure several cytokines and cytokine-related proteins and genotypes in approximately 900 stored samples from WISE participants. Dr. Pepine (U01HL64924) will study the renin angiotensin system in coronary microvascular dysfunction, focusing on whether polymorphisms of the renin-angiotensin/kallikrein-kinin systems and beta-adrenergic receptors polymorphisms are associated with abnormal coronary microvascular function determined by coronary flow reserve measurements.
- Conditions
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
- Being tested
- Angiography, MRI, Dobutamine-Stress Echocardiography, PET,, Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing
- Medical subject headings
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography, MRI, Dobutamine-Stress Echocardiography, PET,Procedure or surgery
Myocardial Contrast Echo, Coronary Flow and Vasomotor TestingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startMay 2001
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sheryl Kelsey, University of PittsburghCarl Pepine, University of FloridaSteven Reis, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000554
- Sponsor's protocol ID
- 98
- Other IDs
- U01HL064829
- Status last verified
- Apr 2014
- First submitted
- 27 Oct 1999
- Last updated
- 4 Apr 2014
- Results posted
- No
Publications
Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999 May;33(6):1453-61. doi: 10.1016/s0735-1097(99)00082-0.
PubMed 10334408Reis SE, Holubkov R, Lee JS, Sharaf B, Reichek N, Rogers WJ, Walsh EG, Fuisz AR, Kerensky R, Detre KM, Sopko G, Pepine CJ. Coronary flow velocity response to adenosine characterizes coronary microvascular function in women with chest pain and no obstructive coronary disease. Results from the pilot phase of the Women's Ischemia Syndrome Evaluation (WISE) study. J Am Coll Cardiol. 1999 May;33(6):1469-75. doi: 10.1016/s0735-1097(99)00072-8.
PubMed 10334410Lewis JF, Lin L, McGorray S, Pepine CJ, Doyle M, Edmundowicz D, Holubkov R, Pohost G, Reichek N, Rogers W, Sharaf BL, Sopko G, Merz CN. Dobutamine stress echocardiography in women with chest pain. Pilot phase data from the National Heart, Lung and Blood Institute Women's Ischemia Syndrome Evaluation (WISE). J Am Coll Cardiol. 1999 May;33(6):1462-8. doi: 10.1016/s0735-1097(99)00076-5.
PubMed 10334409Bittner V, Olson M, Kelsey SF, Rogers WJ, Bairey Merz CN, Armstrong K, Reis SE, Boyette A, Sopko G. Effect of coronary angiography on use of lipid-lowering agents in women: a report from the Women's Ischemia Syndrome Evaluation (WISE) study. For the WISE Investigators. Am J Cardiol. 2000 May 1;85(9):1083-8. doi: 10.1016/s0002-9149(00)00700-1.
PubMed 10781756Bairey Merz CN, Olson M, McGorray S, Pakstis DL, Zell K, Rickens CR, Kelsey SF, Bittner V, Sharaf BL, Sopko G. Physical activity and functional capacity measurement in women: a report from the NHLBI-sponsored WISE study. J Womens Health Gend Based Med. 2000 Sep;9(7):769-77. doi: 10.1089/15246090050147745.
PubMed 11025869Olson MB, Kelsey SF, Bittner V, Reis SE, Reichek N, Handberg EM, Merz CN. Weight cycling and high-density lipoprotein cholesterol in women: evidence of an adverse effect: a report from the NHLBI-sponsored WISE study. Women's Ischemia Syndrome Evaluation Study Group. J Am Coll Cardiol. 2000 Nov 1;36(5):1565-71. doi: 10.1016/s0735-1097(00)00901-3.
PubMed 11079659Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Matthews KA. Psychosocial variables are associated with atherosclerosis risk factors among women with chest pain: the WISE study. Psychosom Med. 2001 Mar-Apr;63(2):282-8. doi: 10.1097/00006842-200103000-00014.
PubMed 11292277Sharaf BL, Pepine CJ, Kerensky RA, Reis SE, Reichek N, Rogers WJ, Sopko G, Kelsey SF, Holubkov R, Olson M, Miele NJ, Williams DO, Merz CN; WISE Study Group. Detailed angiographic analysis of women with suspected ischemic chest pain (pilot phase data from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation [WISE] Study Angiographic Core Laboratory). Am J Cardiol. 2001 Apr 15;87(8):937-41; A3. doi: 10.1016/s0002-9149(01)01424-2.
PubMed 11305981Reis SE, Holubkov R, Conrad Smith AJ, Kelsey SF, Sharaf BL, Reichek N, Rogers WJ, Merz CN, Sopko G, Pepine CJ; WISE Investigators. Coronary microvascular dysfunction is highly prevalent in women with chest pain in the absence of coronary artery disease: results from the NHLBI WISE study. Am Heart J. 2001 May;141(5):735-41. doi: 10.1067/mhj.2001.114198.
PubMed 11320360Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Sharaf B, Matthews KA; Women's Ischemia Syndrome Evaluation (WISE). History of anxiety disorders is associated with a decreased likelihood of angiographic coronary artery disease in women with chest pain: the WISE study. J Am Coll Cardiol. 2001 Mar 1;37(3):780-5. doi: 10.1016/s0735-1097(00)01163-3.
PubMed 11693752Merz NB, Johnson BD, Kelsey PSF, Reis SE, Lewis JF, Reichek N, Rogers WJ, Pepine CF, Shaw LJ; Wise Study Group. Women's Ischemia Syndrome Evaluation. Diagnostic, prognostic, and cost assessment of coronary artery disease in women. Am J Manag Care. 2001 Oct;7(10):959-65.
PubMed 11669360Wild RA, Reis SE. Estrogens, progestins, selective estrogen receptor modulators, and the arterial tree. Am J Obstet Gynecol. 2001 Apr;184(5):1031-9. doi: 10.1067/mob.2001.112902.
PubMed 11303216Holubkov R, Karas RH, Pepine CJ, Rickens CR, Reichek N, Rogers WJ, Sharaf BL, Sopko G, Merz CN, Kelsey SF, McGorray SP, Reis SE. Large brachial artery diameter is associated with angiographic coronary artery disease in women. Am Heart J. 2002 May;143(5):802-7. doi: 10.1067/mhj.2002.121735.
PubMed 12040340Reis SE, Olson MB, Fried L, Reeser V, Mankad S, Pepine CJ, Kerensky R, Merz CN, Sharaf BL, Sopko G, Rogers WJ, Holubkov R. Mild renal insufficiency is associated with angiographic coronary artery disease in women. Circulation. 2002 Jun 18;105(24):2826-9. doi: 10.1161/01.cir.0000021597.63026.65.
PubMed 12070108Bairey Merz CN, Olson MB, Johnson BD, Bittner V, Hodgson TK, Berga SL, Braunstein GD, Pepine CJ, Reis SE, Sopko G, Kelsey SF; Women's Ischemia Syndrome Evaluation. Cholesterol-lowering medication, cholesterol level, and reproductive hormones in women: the Women's Ischemia Syndrome Evaluation (WISE). Am J Med. 2002 Dec 15;113(9):723-7. doi: 10.1016/s0002-9343(02)01366-9.
PubMed 12517361
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Ischemia Syndrome Evaluation (WISE)
- ClinicalTrials.gov ID
- NCT00000554
- Acronym / sponsor ID
- 98
- Conditions
- Angina Pectoris, Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2001
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate innovative diagnostic methods that will improve the diagnostic reliability of cardiovascular testing in evaluation of ischemic heart disease in women. Innovative approaches proposed include physiologic or functional measurements such as impaired metabolism, perfusion, or endothelial function as well as assessment of epicardial coronary arteries by angiography. Other objectives include developing safe, accurate, and cost effective diagnostic approaches for evaluating women with suspected ischemic heart disease, and determining the frequency of myocardial ischemia in the absence of significant epicardial coronary stenosis, as well as the frequency of non-ischemic or non-cardiac chest pain. A key aspect of the WISE study is to determine whether evidence of myocardial ischemia occurs in the absence of obstructive coronary disease.
Detailed description
BACKGROUND:
Cardiovascular disease exacts a heavy burden on the health of women. Ischemic heart disease claims the lives of nearly 250,000 women in the United States each year. Recognition of ischemic heart disease in women is a major challenge to the primary care physician. Diagnosis of ischemic heart disease requires recognition of clinical symptoms such as chest pain, or events such as a myocardial infarction, which are evaluated by a physician who will confirm the diagnosis with objective tests. Unfortunately, both symptom recognition and diagnostic tests confuse rather than confirm a diagnosis of myocardial ischemia in women. Chest pain syndromes suspicious for myocardial ischemia are common in women. Noninvasive diagnostic methods which often confirm the diagnosis and assess disease severity in men are less reliable in women. This lack of objective data to support the diagnosis of chronic or acute myocardial ischemia may influence the physician's decision to further evaluate women at risk. With precision in diagnosis, efforts to optimize therapies are hampered.
The detection of epicardial coronary atherosclerosis is a major objective in clinical cardiology. The utility of this approach is well established. However, although the presence of atherosclerosis is sufficient to cause myocardial ischemia, whether significant ischemia or risk of ischemia exists in the absence of angiographic epicardial stenosis, is not known and may be important for women.
Recent progress in understanding the pathophysiology of myocardial ischemia provides a more complex causal pathway than the heretofore notion of fixed atherosclerotic obstructions in passive conduits. Diseased arteries which may appear angiographically normal as well as arteries with fixed obstructions can respond to vasomotor influences with a detrimental amount of vasoconstriction. The endothelium generates vasoactive and anticoagulant factors that are important mediators of thrombosis. Cycling hormones may further influence these complex interactions. Methods which do not rely solely on fixed obstruction of epicardial arteries are not only possible but may be useful to recognize early atherosclerosis or, for example, endothelial dysfunction which places the patient at risk for untoward coronary events.
The concept for the study was developed by the Cardiology Advisory Committee in collaboration with staff and was approved by the May 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in April 1994.
DESIGN NARRATIVE:
The Women's Ischemia Syndrome Evaluation (WISE) was a four center study designed to evaluate ischemic heart disease and its pathophysiology in women. WISE testing focused on three areas: 1) optimizing symptom evaluation and diagnostic testing for ischemic heart disease; 2) exploring mechanisms for symptoms and evidence of myocardial ischemia in the absence of epicardial coronary artery disease; 3) evaluating the influence of reproductive hormones on symptoms and diagnostic test response. The WISE core data base included demographic and clinical data, symptom and psychosocial variables, coronary angiography and ventriculography data, blood lipoprotein/homocysteine/lipid peroxidation/genetic/hormone/ phytoestrogen analysis, brachial artery reactivity testing, and resting/ambulatory electrocardiographic (ECG) monitoring. Site specific complementary methods included physiologic and functional cardiovascular assessments of myocardial perfusion and metabolism, ventriculography, endothelial vascular function and coronary angiography. Women were followed for at least one year to assess clinical events and symptom status. In the Phase I (1996-7), a pilot phase, 256 women were studied. Phase II has completed enrolling 1008 women in the study. The WISE study defined contemporary and comprehensive state-of-the-art diagnostic testing to evaluate women with suspected ischemic heart disease, and explore sex specific ischemic heart disease pathophysiology.
The study has been renewed through April, 2005 to extend patient follow-up for a minimum of five years. Dr. Kelsey (U01HL64829) of the Data Coordinating Center at the University of Pittsburgh will continue the follow-up, develop sex-specific incremental outcome models to evaluate the prognostic value of female reproductive variables, assess cost effectiveness of the WISE testing techniques, and continue data analyses. Dr. Reis (U01HL64914) will study the immunologic basis of coronary disease in women, focusing on the role of inflammation and cytokine production. He will measure several cytokines and cytokine-related proteins and genotypes in approximately 900 stored samples from WISE participants. Dr. Pepine (U01HL64924) will study the renin angiotensin system in coronary microvascular dysfunction, focusing on whether polymorphisms of the renin-angiotensin/kallikrein-kinin systems and beta-adrenergic receptors polymorphisms are associated with abnormal coronary microvascular function determined by coronary flow reserve measurements.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography, MRI, Dobutamine-Stress Echocardiography, PET, | Procedure or surgery | – |
| Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
- Background: PubMed 10334408Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999 May;33(6):1453-61. doi: 10.1016/s0735-1097(99)00082-0.
- Background: PubMed 10334410Reis SE, Holubkov R, Lee JS, Sharaf B, Reichek N, Rogers WJ, Walsh EG, Fuisz AR, Kerensky R, Detre KM, Sopko G, Pepine CJ. Coronary flow velocity response to adenosine characterizes coronary microvascular function in women with chest pain and no obstructive coronary disease. Results from the pilot phase of the Women's Ischemia Syndrome Evaluation (WISE) study. J Am Coll Cardiol. 1999 May;33(6):1469-75. doi: 10.1016/s0735-1097(99)00072-8.
- Background: PubMed 10334409Lewis JF, Lin L, McGorray S, Pepine CJ, Doyle M, Edmundowicz D, Holubkov R, Pohost G, Reichek N, Rogers W, Sharaf BL, Sopko G, Merz CN. Dobutamine stress echocardiography in women with chest pain. Pilot phase data from the National Heart, Lung and Blood Institute Women's Ischemia Syndrome Evaluation (WISE). J Am Coll Cardiol. 1999 May;33(6):1462-8. doi: 10.1016/s0735-1097(99)00076-5.
- Background: PubMed 10781756Bittner V, Olson M, Kelsey SF, Rogers WJ, Bairey Merz CN, Armstrong K, Reis SE, Boyette A, Sopko G. Effect of coronary angiography on use of lipid-lowering agents in women: a report from the Women's Ischemia Syndrome Evaluation (WISE) study. For the WISE Investigators. Am J Cardiol. 2000 May 1;85(9):1083-8. doi: 10.1016/s0002-9149(00)00700-1.
- Background: PubMed 11025869Bairey Merz CN, Olson M, McGorray S, Pakstis DL, Zell K, Rickens CR, Kelsey SF, Bittner V, Sharaf BL, Sopko G. Physical activity and functional capacity measurement in women: a report from the NHLBI-sponsored WISE study. J Womens Health Gend Based Med. 2000 Sep;9(7):769-77. doi: 10.1089/15246090050147745.
- Background: PubMed 11079659Olson MB, Kelsey SF, Bittner V, Reis SE, Reichek N, Handberg EM, Merz CN. Weight cycling and high-density lipoprotein cholesterol in women: evidence of an adverse effect: a report from the NHLBI-sponsored WISE study. Women's Ischemia Syndrome Evaluation Study Group. J Am Coll Cardiol. 2000 Nov 1;36(5):1565-71. doi: 10.1016/s0735-1097(00)00901-3.
- Background: PubMed 11292277Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Matthews KA. Psychosocial variables are associated with atherosclerosis risk factors among women with chest pain: the WISE study. Psychosom Med. 2001 Mar-Apr;63(2):282-8. doi: 10.1097/00006842-200103000-00014.
- Background: PubMed 11305981Sharaf BL, Pepine CJ, Kerensky RA, Reis SE, Reichek N, Rogers WJ, Sopko G, Kelsey SF, Holubkov R, Olson M, Miele NJ, Williams DO, Merz CN; WISE Study Group. Detailed angiographic analysis of women with suspected ischemic chest pain (pilot phase data from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation [WISE] Study Angiographic Core Laboratory). Am J Cardiol. 2001 Apr 15;87(8):937-41; A3. doi: 10.1016/s0002-9149(01)01424-2.
- Background: PubMed 11320360Reis SE, Holubkov R, Conrad Smith AJ, Kelsey SF, Sharaf BL, Reichek N, Rogers WJ, Merz CN, Sopko G, Pepine CJ; WISE Investigators. Coronary microvascular dysfunction is highly prevalent in women with chest pain in the absence of coronary artery disease: results from the NHLBI WISE study. Am Heart J. 2001 May;141(5):735-41. doi: 10.1067/mhj.2001.114198.
- Background: PubMed 11693752Rutledge T, Reis SE, Olson M, Owens J, Kelsey SF, Pepine CJ, Reichek N, Rogers WJ, Merz CN, Sopko G, Cornell CE, Sharaf B, Matthews KA; Women's Ischemia Syndrome Evaluation (WISE). History of anxiety disorders is associated with a decreased likelihood of angiographic coronary artery disease in women with chest pain: the WISE study. J Am Coll Cardiol. 2001 Mar 1;37(3):780-5. doi: 10.1016/s0735-1097(00)01163-3.
- Background: PubMed 11669360Merz NB, Johnson BD, Kelsey PSF, Reis SE, Lewis JF, Reichek N, Rogers WJ, Pepine CF, Shaw LJ; Wise Study Group. Women's Ischemia Syndrome Evaluation. Diagnostic, prognostic, and cost assessment of coronary artery disease in women. Am J Manag Care. 2001 Oct;7(10):959-65.
- Background: PubMed 11303216Wild RA, Reis SE. Estrogens, progestins, selective estrogen receptor modulators, and the arterial tree. Am J Obstet Gynecol. 2001 Apr;184(5):1031-9. doi: 10.1067/mob.2001.112902.
Related trials for Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Kelsey
University of Pittsburgh
Carl Pepine
University of Florida
Steven Reis
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angiography, MRI, Dobutamine-Stress Echocardiography, PET, and Myocardial Contrast Echo, Coronary Flow and Vasomotor Testing in people with Angina Pectoris and Cardiovascular Diseases, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000554, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.