Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02008786 |
| Other study ID # |
SAFER-SCAD |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 2014 |
| Est. completion date |
September 13, 2019 |
Study information
| Verified date |
March 2024 |
| Source |
Cardiology Research UBC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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) < 2.5 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 (e.g. 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 <3.0 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
<2.5 and that their IMR will be abnormal. Further, we hypothesize that the addition of either
an ACEI and/or statin will improve chest pain frequency by at least 20 points on the SAQ at
16 weeks compared to placebo.
