Trial Outcomes & Findings for Women With Chest Pain and Normal Coronary Arteries Study (NCT NCT00743197)

Results Overview

The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

1 year

Results posted on

2023-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Group USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.	Medical Treatment Group TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
Overall Study STARTED	1	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Group USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.	Medical Treatment Group TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
Overall Study Study terminated due to departure of PI.	1	2

Baseline Characteristics

Women With Chest Pain and Normal Coronary Arteries Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Group n=1 Participants USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician.	Medical Treatment Group n=2 Participants TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.

The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medical Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martha Gulati, Principal Investigator

Northwestern University

Phone: 312-695-4965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place