N/A
N=1,202
Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease-2
Coronary Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01664858 ↗Enrolled (actual)
1,202
Serious AEs
3.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Unnecessary Invasive Coronary Angiography — 36; 34; 69 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3T CMR (Other); SPECT (Other); CT calcium score (Other); CT coronary angiography (Other); X-Ray coronary angiography (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Leeds
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unnecessary Invasive Coronary Angiography |
36; 34; 69 | — |
| SECONDARY Major Adverse Cardiovascular Event (MACE) |
20; 17; 4 | — |
| SECONDARY Positive Angiogram (by FFR) Rate for Each Strategy. |
47; 42; 29 | — |
| SECONDARY Cost Effectiveness Analysis |
— | — |
| SECONDARY Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D) |
— | — |
| SECONDARY Complications |
— | — |
Summary
CE-MARC 2 is a randomised controlled trial to determine diagnosis and patient management in patients presenting to outpatient clinics with suspected stable angina. Cardiac Magnetic Resonance Imaging (at 3Tesla) will be evaluated prospectively against current best clinical practice (defined by international guidelines). The study hypothesis is that 3Tesla CMR-guided management of patients with suspected stable angina is superior to current clinical practice based on 1) the principles of the National Institutes for Clinical Excellence (NICE) CG95 guidelines (2010); 2) SPECT AHA appropriateness criteria, in terms of avoiding study-defined unnecessary invasive coronary angiography.
Eligibility Criteria
Inclusion Criteria
- Patient ≥30yrs
- Patient has suspected stable angina (CHD) that requires further investigation
- Has a defined risk of 10-90% (according to NICE guidelines CG95; 2010)
- Suitable for revascularisation if required
- Given informed written consent
Exclusion Criteria
- Non-anginal chest pain
- Clinically unstable
- Previous MI or biomarker positive ACS
- Previous revascularisation with coronary artery bypass surgery or PCI
- Contraindication to CMR imaging (pacemaker, intra-orbital debris, intra-auricular implants, intracranial clips, severe claustrophobia)
- Contraindication to adenosine infusion (regular adenosine antagonist medication, significant reversible airways disease, second or third degree atrio-ventricular heart block, sino-atrial disease)
- Known adverse reaction to Adenosine or Gadolinium contrast agent
- Obesity (where body girth exceeds scanner diameter)
- Pregnancy or breast feeding
- Inability to give informed consent
- Known chronic renal failure (eGFR <30mL/min/1.73m2)
Data sourced from ClinicalTrials.gov (NCT01664858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.