Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02008786
Status:
TERMINATED
Last Update Posted:
2024-03-15
First Post:
2013-12-07
Brief Title:
Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
The Effects of Statin and Angiotensin-converting Enzyme Inhibitor on Coronary Flow Reserve indEx of Microcirculatory Resistance and Symptoms in Patients With Spontaneous Coronary Artery Dissection SAFER-SCAD Study
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFER-SCAD
Brief Summary:
An emerging cause of heart attack in young women is a dissection or tear in the coronary arteries Many of these young women continue to have chest pain long after the tear has healed and this is thought to be due to problems with their small blood vessels of the heart or microcirculation We want to determine whether commonly used medications for coronary artery disease including statins for cholesterol and angiotensin-converting enzyme inhibitors for blood pressure reduce chest pain and improve small vessel function in these patients
Detailed Description:
In patients with spontaneous coronary artery dissection SCAD many continue to have ongoing signs and symptoms of ischemia after the dissection has healed Further 1 in 5 women will experience recurrent SCAD in long-term follow-up To date no study has investigated the pathophysiologic mechanism behind ongoing symptoms or recurrence of SCAD but microvascular coronary dysfunction MCD has been suggested Coronary reactivity testing CRT is an invasive procedure currently being done in MCD patients as the gold standard technique In particular a coronary flow reserve CFR 25 has been shown to be both diagnostic of the condition and prognostic of a 2 fold increased risk of cardiac events Please see below for a detailed description of CRT In brief a dual temperature and pressure sensor tipped wire by Radi Medical Systems St Jude Medical St Paul MN will be placed into the dissected and non-dissected coronary arteries of the patient This will measure CFR by thermodilution and will also allow the measurement of the index of microcirculatory resistance IMR IMR has been found to correlate well with true microvascular resistance
In addition to a lack of diagnostic strategies there is a paucity of research into therapeutic strategies Most women are conservatively managed with medications however there is no consensus as to which pharmacologic therapies should be used Case reports have suggested benefit with antiplatelet agents eg aspirin and beta-blockers reduction of arterial wall shear stress To date no study has investigated the effects of statins or Angiotensin Converting Enzyme Inhibitors ACEIs in SCAD patients Both agents have been studied in the MCD population and been found to reduce angina frequency and improve CFR after 16 weeks
Purpose
To measuring the CFR and IMR in 40 SCAD patients with ongoing chest pain who are at least 3 months from their dissection to determine the proportion with microvascular dysfunction and to investigate prospectively whether the addition of an ACEI or a statin to usual care in patients with ongoing chest pain and a CFR 30 improves chest pain frequency by Seattle Angina Questionnaire SAQ at 16 weeks compared to placebo
Hypothesis
We hypothesize that the average CFR in patients at least 3 months out from their SCAD will be 25 and that their IMR will be abnormal Further we hypothesize that the addition of either an ACEI andor statin will improve chest pain frequency by at least 20 points on the SAQ at 16 weeks compared to placebo
In addition to a lack of diagnostic strategies there is a paucity of research into therapeutic strategies Most women are conservatively managed with medications however there is no consensus as to which pharmacologic therapies should be used Case reports have suggested benefit with antiplatelet agents eg aspirin and beta-blockers reduction of arterial wall shear stress To date no study has investigated the effects of statins or Angiotensin Converting Enzyme Inhibitors ACEIs in SCAD patients Both agents have been studied in the MCD population and been found to reduce angina frequency and improve CFR after 16 weeks
Purpose
To measuring the CFR and IMR in 40 SCAD patients with ongoing chest pain who are at least 3 months from their dissection to determine the proportion with microvascular dysfunction and to investigate prospectively whether the addition of an ACEI or a statin to usual care in patients with ongoing chest pain and a CFR 30 improves chest pain frequency by Seattle Angina Questionnaire SAQ at 16 weeks compared to placebo
Hypothesis
We hypothesize that the average CFR in patients at least 3 months out from their SCAD will be 25 and that their IMR will be abnormal Further we hypothesize that the addition of either an ACEI andor statin will improve chest pain frequency by at least 20 points on the SAQ at 16 weeks compared to placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None